Pyzchiva 45 mg solution for injection in pre-filled syringe

Spain
Brand name Pyzchiva 45 mg solution for injection in pre-filled syringe
Form solution for injection in a pre-filled syringe
Active substance / Dosage
USTEKINUMAB · 45 mg
Prescription type Hospital Diagnosis
Registration number 1241801001
Pyzchiva 45 mg solution for injection in pre-filled syringe solution for injection in a pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pyzchiva 45 mg solution for injection in pre-filled syringe

ustekinumab

This medicinal product is subject to additional monitoring, which will allow for faster detection 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 Pyzchiva 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, because 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.

Contents of the leaflet

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

1. What Pyzchiva is and what it is used for

What Pyzchiva is

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

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

What Pyzchiva is used for

Pyzchiva is used to treat the following inflammatory conditions:

  • Plaque psoriasis – in adults and children aged 6 years and older
  • Psoriatic arthritis – in adults
  • Moderate to severe Crohn’s disease – in adults and children weighing at least 40 kg

Plaque psoriasis

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

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

Pyzchiva 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 when these treatments are ineffective.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease, which is usually accompanied by 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 Pyzchiva 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 those medications, you may be given Pyzchiva to reduce the signs and symptoms of your disease.

2. What you need to know before using Pyzchiva

Do not use Pyzchiva

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Pyzchiva. Your doctor will assess your condition before each treatment. Make sure to inform your doctor about any illness you may have before each treatment. Your doctor will also ask whether you have recently been in contact with anyone who might have tuberculosis. Your doctor will examine you and perform a test to detect tuberculosis before you start using Pyzchiva. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Watch for serious adverse effects

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

Before using Pyzchiva, tell your doctor:

  • If you have ever had an allergic reaction to ustekinumab. Consult your doctor if you are unsure.
  • If you have ever had any type of cancer – because immunosuppressants like ustekinumab weaken part of the immune system, which may increase the risk of developing cancer.
  • If you have previously been treated for psoriasis with other biologics (a medicine produced from a biological source and usually administered by injection) – the risk of developing cancer may be higher.
  • If you have or have recently had an infection.
  • If you have any new skin lesions or changes in existing lesions within the psoriasis area or on intact skin.
  • If you are receiving 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 combined use of these treatments with ustekinumab has not been studied, but it may increase the likelihood of developing diseases related to a weakened immune system.
  • If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether ustekinumab 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 Pyzchiva.

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, in 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 ustekinumab. 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 ustekinumab is not recommended in children under 6 years of age with psoriasis, in children with Crohn’s disease weighing less than 40 kg, or in children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.

Use of Pyzchiva with other medicines and vaccines

Inform your doctor or pharmacist:

  • If you are currently using, have recently used, or might use 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 receiving Pyzchiva.
  • If you received Pyzchiva during pregnancy, inform your infant’s doctor about your Pyzchiva treatment before your infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your infant during the first twelve months after birth if you received Pyzchiva 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 ustekinumab in utero. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using ustekinumab during pregnancy.
  • Women of childbearing potential are advised to avoid becoming pregnant and to use adequate contraception while receiving ustekinumab and for at least 15 weeks after the last dose of ustekinumab.
  • Pyzchiva can cross the placenta to the fetus. If you received Pyzchiva 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 Pyzchiva during pregnancy before your infant receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your infant during the first twelve months after birth if you received Pyzchiva 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 ustekinumab. Do not do both at the same time.

Driving and use of machines

The influence of ustekinumab on the ability to drive and use machines is negligible or none.

Pyzchiva contains polysorbate 80 (E433)

This medicine contains 0.02 mg of polysorbate 80 (E433) in each pre-filled syringe (1 ml), equivalent to 0.02 mg/0.5 ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Pyzchiva

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

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

What dose of Pyzchiva is administered

Your doctor will decide the dose of Pyzchiva 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 Pyzchiva. 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 Pyzchiva as an intravenous infusion (into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Pyzchiva 8 weeks later, and thereafter every 12 weeks, by subcutaneous injection (“under the skin”).
  • In some patients, after the first subcutaneous injection, 90 mg of Pyzchiva 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 Pyzchiva 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 require a lower dose than the full 45 mg dose.
  • If you weigh less than 60 kg, the recommended dose is 0.75 mg of Pyzchiva per kg of body weight.
  • If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Pyzchiva.
  • If you weigh more than 100 kg, the recommended dose is 90 mg of Pyzchiva.
  • After the initial dose, you will receive the next dose 4 weeks later, and subsequently every 12 weeks.

Children weighing at least 40 kg

Crohn’s disease

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

How Pyzchiva is administered

  • Pyzchiva is administered by subcutaneous injection (“under the skin”). At the beginning of your treatment, medical or nursing staff may administer Pyzchiva to you.

  • However, you and your doctor may decide that you can self-inject Pyzchiva. In that case, you will be trained on how to self-inject Pyzchiva.

  • For instructions on how to inject Pyzchiva, see “Instructions for administration” at the end of this leaflet.

Consult your doctor if you have any questions about how to self-inject.

If you use more Pyzchiva than you should

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

If you forget to use Pyzchiva

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

If you stop using Pyzchiva

Stopping ustekinumab 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 experiences 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 ustekinumab (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 (these may affect up to 1 in 100 people).

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

If you have a severe allergic reaction, your doctor may decide that you should not use Pyzchiva again.

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).

Ustekinumab may affect your ability to fight infections. Some of these infections could become serious and may be caused by viruses, fungi, bacteria (including tuberculosis), or parasites. They include infections that occur mainly 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 ustekinumab. These include:

  • fever, flu-like symptoms, night sweats, weight loss,
  • feeling tired or short of breath; persistent cough,
  • skin that is warm, red, and painful, or a painful skin rash with blisters,
  • burning sensation when urinating,
  • diarrhea,
  • visual deterioration or loss of vision,
  • headache, neck stiffness, light sensitivity, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to serious complications. You should also inform your doctor if you have any infection that does not go away or keeps returning. Your doctor may decide that you should not use ustekinumab 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 peeling of the skin over a large area of the body 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 sinking of the muscles 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 on the skin, sometimes accompanied by fever (pustular psoriasis)
  • Skin peeling (skin exfoliation)
  • Acne

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

  • Redness and peeling of the skin over a large area of the body, 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 in 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 may 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 Pyzchiva

  • Keep this medicine out of the sight and reach of children.
  • Store in a refrigerator (2 °C to 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 Pyzchiva may also be stored at room temperature up to 30 °C for a single period of up to 35 days in their original carton to protect them from light. Write the date on which the pre-filled syringe was first removed from the refrigerator in the designated space on the outer packaging. At any time before the end of this period, the syringe may be returned to the refrigerator once and stored there until the original expiry date. Discard the syringe if it is not used within the maximum 35-day period of storage at room temperature or after the original expiry date, whichever occurs first.
  • Do not shake the pre-filled syringes of Pyzchiva. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

  • After the expiry date stated on the label and packaging after “CAD/EXP”. The expiry date refers to the last day of the month indicated.
  • If the liquid changes colour, becomes cloudy, or contains foreign particles floating in it (see section 6 “What Pyzchiva looks like and contents of the pack”).
  • If you know or suspect it has been exposed to extreme temperatures (such as accidental overheating or freezing).
  • If the product has been shaken vigorously.

Pyzchiva is for single use only. Any unused product 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 medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pyzchiva

  • The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 ml.
  • The other components are histidine, monohydrate histidine hydrochloride, polysorbate 80 (E 433), sucrose, water for injections.

Appearance of Pyzchiva and contents of the pack

Pyzchiva is a clear, colourless to pale yellow injectable solution. The solution may contain a few translucent or white protein particles. It is supplied in a pack containing 1 single-dose glass pre-filled syringe of 1 ml. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 ml of injectable solution.

Marketing Authorization Holder and Manufacturer

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium

Sandoz nv/sa

Tel/Tel: +32 2 722 97 97

Lithuania

Sandoz Pharmaceuticals d.d. branch

Tel: +370 5 2636 037

Text in Cyrillic characters on a white background stating 'Bulgaria, Sandoz Bulgaria KCT' and the telephone number +359 2 970 47 47

Luxembourg/Luxembourg

Sandoz nv/sa

Tel./Tel.: +32 2 722 97 97

Czech Republic

Sandoz s.r.o.

Tel: +420 225 775 111

Hungary

Sandoz Hungária Kft.

Tel.: +36 1 430 2890

Denmark/Norway/Iceland/Sweden

Sandoz A/S

Tlf: +45 63 95 10 00

Malta

Sandoz Pharmaceuticals d.d.

Tel: +356 99644126

Germany

Hexal AG

Tel: +49 8024 908 0

Netherlands

Sandoz B.V.

Tel: +31 36 52 41 600

Estonia

Sandoz d.d. Estonian branch

Tel: +372 665 2400

Austria

Sandoz GmbH

Tel: +43 5338 2000

Greece

SANDOZ HELLAS MONOPROSOPHI S.A.

Tel: +30 216 600 5000

Poland

Sandoz Polska Sp. z o.o.

Tel.: +48 22 209 70 00

Spain

Sandoz Farmacéutica, S.A.

Tel: +34 900 456 856

Portugal

Sandoz Farmacêutica Lda.

Tel: +351 21 000 86 00

France

Sandoz SAS

Tél: +33 1 49 64 48 00

Romania

Sandoz Pharmaceuticals SRL

Tel: +40 21 407 51 60

Croatia

Sandoz d.o.o.

Tel: +385 1 23 53 111

Slovenia

Sandoz farmacevtska družba d.d.

Tel: +386 1 580 29 02

Ireland

Rowex Ltd.

Tel: +353 27 50077

Slovakia

Sandoz d.d. - organizational unit

Tel: +421 2 48 200 600

Italy

Sandoz S.p.A.

Tel: +39 02 81280696

Finland/Finland

Sandoz A/S

Puh/Tel: +358 10 6133 400

Cyprus

SANDOZ HELLAS MONOPROSOPHI S.A.

Tel: +30 216 600 5000

Latvia

Sandoz d.d. Latvia branch

Tel: +371 67 892 006

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.

Date of the most recent review of this leaflet: MM/YYYY

Other sources of information

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

Instructions for administration

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-administer Pyzchiva. In such case, you will be trained on how to inject yourself with Pyzchiva. Speak with your doctor if you have any doubts about administering the injections.

  • Do not mix Pyzchiva with other injectable liquids.
  • Do not shake the prefilled syringes. The medicine may become damaged if shaken vigorously. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows what the prefilled syringe looks like.

Technical diagram of a syringe with Spanish labels indicating needle, cap, barrel, viewing window, label, protector wings, plunger, and tip
  1. Check the number of prefilled syringes and prepare materials:

Preparation for using the prefilled syringe

  • Remove the prefilled syringe(s) from the refrigerator. Leave the prefilled syringe outside the carton for 30 minutes. This will allow the liquid to reach a comfortable temperature for administration (room temperature). Do not heat the prefilled syringe in any other way (for example, do not heat it in a microwave or in hot water). Do not remove the needle cap while waiting for the syringe to reach room temperature.
  • Hold the prefilled syringe by the barrel with the needle cap pointing upwards.
  • Do not hold the syringe by the plunger head, plunger, needle shield wings, or needle cap.
  • Do not pull back the plunger at any time.
  • Do not remove the cap from the prefilled syringe until instructed to do so.

Check the prefilled syringe(s) to ensure that

  • The number of prefilled syringes and concentration are correct
    • If your dose is 45 mg, you will have one prefilled syringe containing 45 mg of Pyzchiva.
    • If your dose is 90 mg, you will have two prefilled syringes containing 45 mg of Pyzchiva each, and you 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 expiry date has not passed.
  • The prefilled syringe is not damaged.
  • The solution in the prefilled syringe is clear and colourless to slightly yellow.
  • The solution in the prefilled syringe does not have an abnormal colour, is not cloudy, and does not contain foreign particles.
  • The solution in the prefilled syringe is not frozen.

Prepare all the materials you need and place them on a clean surface. Include antiseptic wipes, cotton wool or gauze, and a sharps container.

  1. Choose and prepare the injection site:

Choose the injection site (see Figure 2).

  • Pyzchiva is administered by injection under the skin (subcutaneously).
  • Suitable injection sites include the upper thigh or the abdominal area (abdomen), at least 5 cm away from the navel.
  • As far as possible, avoid areas of skin showing signs of psoriasis.
  • If someone else is administering the injection, they may also choose the upper arm as an injection site.
Schematic drawing of a male torso and leg with gray areas indicating recommended injection sites

Prepare the injection site

  • Wash your hands thoroughly with soap and lukewarm water.
  • Clean the skin at the injection site with an antiseptic wipe.
  • Do not touch this area again before administering the injection.
  • Do not fan or blow on the cleaned area.
  1. Remove the needle cap (see Figure 3):
    • The needle cap must not be removed until you are ready to inject.
    • Hold the prefilled syringe and grip the barrel of the syringe with one hand.
    • Remove the needle cap and dispose of it. Do not touch the plunger while doing this.
Two hands holding a syringe with needle and black arrows indicating a horizontal back-and-forth movement above the caption Figure 3
  • You may see an air bubble in the prefilled syringe or a drop of liquid at the end 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 prefilled 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. Inject the dose:
    • Hold the prefilled 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 with your thumb and index finger. Do not squeeze tightly.
    • Do not pull back the plunger at any time.
    • With one quick motion, insert the needle through the skin as far as it will go (see Figure 4).
Line drawing of two hands holding a syringe with needle preparing to perform an injection
  • Inject all the medicine by pushing the plunger until the plunger head is completely between the needle shield wings (see Figure 5).
Black-and-white technical illustration showing a hand holding and operating a syringe-shaped medical device with the caption Figure 5
  • When you have pushed the plunger as far as it will go, maintain pressure on the plunger head, withdraw the needle, and release the skin (see Figure 6).
A hand holding an injection pen at an angle to insert the needle
  • Slowly remove your thumb from the plunger head to allow the empty syringe to move forward until the needle is completely covered by the needle shield, as shown in Figure 7:
A hand holding a prefilled syringe tilted forward for injection
  1. After the injection:

    • Press the injection site with an antiseptic wipe for a few 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 it for 10 seconds.
    • Do not rub the skin at the injection site. You may cover the injection site with a plaster if necessary.
  2. Disposal:

    • Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your safety and health, and for 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 the regular trash.
A hand holds a syringe above a biohazard waste container with a biological hazard symbol for safe disposal