Piasky

Patient Information Leaflet

Piasky 340 mg solution for injection or infusion

crovalimab
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

In addition to this leaflet, your doctor will provide you with a “Patient Reminder Card” listing the signs of meningococcal infection and sepsis:

• carry it with you at all times during treatment and
• for 11 months after your last dose of Piasky

Contents of this leaflet

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

1. What Piasky is and what it is used for

What Piasky is
Piasky contains the active substance crovalimab. This belongs to a class of medicines known as
"monoclonal antibodies", which are proteins designed to bind to a specific target in the body. Piasky is
also referred to as a complement component 5 (C5) inhibitor.
What Piasky is used for
Piasky is used to treat a disease called paroxysmal nocturnal haemoglobinuria (PNH). It is used in
adults and children aged 12 years and older and weighing 40 kg or more, including patients with
haemolysis (breakdown of red blood cells) and clinical symptoms indicating high disease activity, as
well as patients with stable disease after treatment with a C5 inhibitor for at least the last 6 months.
PNH can cause the immune system to attack the body's red blood cells, leading to haemolysis which
may result in:

• symptoms of anaemia (low red blood cell levels), such as feeling tired or lacking energy and dark-coloured urine;
• stomach pain;
• difficulty swallowing;
• difficulty achieving or maintaining an erection (erectile dysfunction);
• kidneys not working properly;
• blood clots with symptoms such as progressive swelling of one leg or shortness of breath during physical activity.

Patients with PNH may require regular blood transfusions.
How Piasky works
The active substance in Piasky, crovalimab, binds to complement protein 5 (C5), which is part of the
body's defence system known as the "complement system". By doing so, it blocks the activation of
C5, thereby preventing the immune system from attacking and damaging red blood cells, thus reducing
the breakdown of red blood cells. This helps reduce the symptoms of PNH and the number of blood
transfusions required.

2. What you need to know before using Piasky

Do not use Piasky

• if you are allergic to crovalimab or to any of the other ingredients of this medicine (listed in section 6)
• if you have a meningococcal infection (a serious bacterial infection caused by Neisseria meningitidis that can affect the membranes covering the brain and spinal cord and spread through the bloodstream)
• if you have not been vaccinated against meningococcal infection, unless you are receiving preventive antibiotic treatment until 2 weeks after receiving this vaccination.

Do not use Piasky if any of the above conditions apply to you. If you are in doubt, consult your
doctor, pharmacist, or nurse before using Piasky.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Piasky.
Severe meningococcal infections
Piasky may increase the risk of meningococcal infections caused by Neisseria meningitidis bacteria
because it blocks part of the immune system. These include serious infections such as septicemia
(blood poisoning) and meningitis (inflammation of the membranes surrounding the brain and
spinal cord).

• Inform your doctor immediately if you experience any of the following signs, which may indicate a meningococcal infection:
  • fever;
  • feeling unwell (nausea);
  • vomiting;
  • headache;
  • confusion or irritability;
  • stiff neck or back;
  • muscle pain, with flu-like signs or symptoms;
  • sensitivity to light;
  • skin rash or spots on the skin.

Talk to your doctor before starting Piasky to ensure your meningococcal infection vaccination is up to date; complete vaccination is required at least
2 weeks before starting Piasky. Even if you were vaccinated as a child, your doctor may
decide that you need to be vaccinated again.
If you are not fully vaccinated but need Piasky immediately, you should be vaccinated as soon as
possible. To reduce the risk of infection, your doctor will prescribe antibiotics from the time you
start Piasky until 2 weeks after vaccination.
Vaccination does not always prevent this type of infection. Your doctor may decide that
you need additional measures to prevent infection.
Patient alert card
Your doctor will give you a “Patient alert card” listing the signs of meningococcal infection
and sepsis:

• carry it with you at all times during treatment with Piasky, and
• for 11 months after your last dose of Piasky.

Other serious infections
Piasky may also increase the risk of other serious infections, such as those caused by
Streptococcus pneumoniae and Haemophilus influenzae.

• Inform your doctor or pharmacist if you experience any of the following signs, which may indicate an infection:
  • fever;
  • cough;
  • chest pain;
  • fatigue;
  • shortness of breath;
  • painful skin rash;
  • sore throat;
  • pain/burning when urinating;
  • feeling weak or generally unwell.

Inform your doctor before starting Piasky to ensure your vaccination against infections caused by
Streptococcus pneumoniae and Haemophilus influenzae is up to date (you must be
fully vaccinated at least 2 weeks before starting Piasky). Even if you were vaccinated as a child, your doctor may decide that you need to be vaccinated again.
If you are not fully vaccinated but need to start Piasky immediately, you should be vaccinated as soon
as possible. To reduce the risk of infection, your doctor will prescribe antibiotics from the time you
start Piasky until 2 weeks after vaccination.
Your doctor may recommend additional vaccinations before treatment. Check with your
doctor before starting treatment.
Reaction following switch from another C5 inhibitor
Before taking Piasky, inform your doctor if you have ever been treated with any other C5 inhibitor. This is because during the first 30 days after switching from another C5 inhibitor to Piasky,
you may experience a temporary type of reaction known as type III immune complex-mediated reaction. This may also occur if you stop Piasky and switch to another C5 inhibitor.

• Inform your doctor if you experience signs of this type of reaction, such as:
  • joint pain or other problems related to muscles, bones, and tissues;
  • numbness and tingling or a pins-and-needles sensation, especially in hands and feet;
  • skin rash or other skin problems;
  • fever.

Infusion- and injection-related reactions
When Piasky is administered by intravenous infusion (drip into a vein) or subcutaneous injection (injection under the skin), it may cause infusion- or injection-related reactions. Inform your
doctor or nurse immediately if you experience any of the following signs, which may indicate an infusion or injection reaction:

• headache;
• back pain;
• pain at the infusion site or other sites;
• swelling;
• bruising or bleeding;
• skin redness;
• itching or skin rash.

You may also experience an allergic reaction to the infusion or injection. Inform your doctor or nurse immediately if you experience any of the following signs of a severe allergic reaction:

• tightness in the chest or wheezing;
• feeling short of breath;
• fever or chills;
• severe dizziness or mild confusion;
• swelling of lips, tongue, or face;
• skin itching, hives, or rash.

If you have experienced an infusion or injection reaction, including an allergic reaction, you must discuss with your doctor or nurse whether treatment with Piasky should continue.
Discontinuation of Piasky treatment
If you stop taking Piasky and do not switch to another treatment for PNH, contact your doctor
immediately if you develop symptoms indicating intravascular hemolysis (breakdown of red blood cells in blood vessels), including:

• symptoms of anemia (low red blood cell levels), such as feeling tired or lacking energy and dark urine;
• abdominal pain;
• difficulty swallowing;
• difficulty achieving or maintaining an erection (erectile dysfunction);
• kidneys not working properly;
• blood clots, with symptoms such as progressive swelling in one leg or shortness of breath that prevents you from performing strenuous activities.

Formation of antibodies (immunogenicity)
Your immune system may produce antibodies (proteins made by the body against an unwanted substance) against crovalimab, potentially leading to a reduced or lost response to
Piasky. Inform your doctor immediately if you experience any of the following symptoms:

• symptoms of anemia (low red blood cell levels), such as feeling tired or lacking energy and dark urine;
• abdominal pain;
• difficulty swallowing;
• difficulty achieving or maintaining an erection (erectile dysfunction);
• kidneys not working properly;
• blood clots with symptoms such as progressive swelling in one leg or shortness of breath that prevents you from performing strenuous activities.

Children and adolescents
Do not administer Piasky to children under 12 years of age or to children weighing less than 40 kg.
This is because it has not yet been studied in these groups.
Other medicines and Piasky
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take
any other medicines.
In particular, you must inform your doctor if you are currently being treated or have ever been treated with
any other C5 inhibitor. This is because you may experience a temporary type of reaction known
as a type III immune complex-mediated reaction (see “Warnings and precautions”).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.
There is no information available on the use of Piasky in pregnant women, and its effects on the fetus are unknown. Your doctor will discuss with you the potential risks of using Piasky during
pregnancy.
If you are breastfeeding, it is not known whether Piasky passes into breast milk, but given its characteristics, it is expected to pass into milk. Your doctor will discuss with you the potential risks of using Piasky during
breastfeeding.
Driving and using machines
Piasky has no effect or negligible effect on the ability to drive vehicles and use machines.

3. How to use Piasky

Use this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor.

Vaccines administered before using Piasky
At least 2 weeks before starting treatment with Piasky, your doctor will administer a vaccine against meningococcal infections if you have never received one before or if your previous vaccination is no longer valid.
If you start treatment with Piasky less than 2 weeks after receiving this vaccine, your doctor will prescribe antibiotics for at least 2 weeks after vaccination to reduce the risk of infection.

How to use Piasky
Piasky is administered either as an intravenous infusion (a drip into a vein) or as an injection under the skin (subcutaneous injection).
Only the first dose will be given by intravenous infusion by a healthcare professional. Subsequent doses are administered as subcutaneous injections. After receiving instructions, you or the person assisting you may administer the subcutaneous injection of Piasky at home without medical supervision.
Your doctor or nurse will provide instructions on how to prepare the medicine and how to administer the subcutaneous injections to yourself or others. Read carefully and follow the instructions in the section “Instructions for use” at the end of this leaflet.

When to use Piasky
The first dose will be administered on Day 1 by a healthcare professional. This is the first loading dose, which is higher than the doses given later during treatment. Additional loading doses will be administered on Days 2, 8, 15, and 22.
Afterwards, Piasky will be administered on Day 29 and then every 4 weeks as a subcutaneous injection. These are the maintenance doses.
If you were previously treated with another medicine for PNH, known as a "complement inhibitor", the first loading dose of Piasky must be administered according to the scheduled timing for the next dose of that medicine.

How much Piasky to use
Your doctor will prescribe a dose and treatment schedule based on your body weight.
If your weight is equal to or greater than 40 kg but less than 100 kg:

• the first loading dose on Day 1 will be 1,000 mg, administered by intravenous infusion over 60 minutes;
• on Days 2, 8, 15, and 22, subsequent loading doses will be 340 mg administered as a single subcutaneous injection;
• you will receive a maintenance dose of 680 mg, administered as two subcutaneous injections, on Day 29 and then every 4 weeks.

If you weigh 100 kg or more:

• the first loading dose on Day 1 will be 1,500 mg, administered by intravenous infusion over 90 minutes;
• on Days 2, 8, 15, and 22, subsequent loading doses will be 340 mg administered as a single subcutaneous injection;
• you will receive a maintenance dose of 1,020 mg, administered as three subcutaneous injections, on Day 29 and then every 4 weeks.

Your maintenance dose may change if your weight changes during treatment with Piasky.
Inform your doctor if your weight increases above or drops below 100 kg. Your doctor or nurse should monitor your body weight regularly.

If you use more Piasky than you should
If you think you have used more Piasky than prescribed, seek advice from your doctor, pharmacist, or nurse.

If you forget to use Piasky
For the treatment to be fully effective, it is very important to use Piasky exactly as prescribed.

• If you miss an appointment with your doctor or nurse to receive your injections, schedule another one immediately.
• If you or the person assisting you forgets to inject all or part of a dose of Piasky at home, take the missed dose or the missed part of the dose as soon as possible, then continue with the next dose at the regularly scheduled time. Do not double the dose to make up for a missed dose. If you have any doubts, consult your doctor, pharmacist, or nurse.

If you stop using Piasky
Do not stop treatment with Piasky without first discussing it with your doctor. Stopping treatment will interrupt the effect of the medicine, which may cause the return or worsening of symptoms of PNH.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Before treatment, your doctor will discuss with you the possible side effects and explain the risks and benefits of Piasky.
Piasky can cause some side effects that require you to inform your doctor immediately.
The most serious side effects are meningococcal infection and severe allergic reaction.

• If you experience any of the following signs of meningococcal infection, you must inform your doctor immediately:
  • fever
  • feeling unwell (nausea or vomiting)
  • headache
  • confusion or irritability
  • stiff neck or back
  • muscle pain with flu-like symptoms
  • sensitivity of the eyes to light
  • skin rashes or spots
• If you experience any of the following signs of a severe allergic reaction, you must inform your doctor immediately:
  • tightness in the chest or wheezing
  • feeling short of breath
  • fever or chills
  • severe dizziness
  • mild confusion
  • swelling of lips, tongue, or face
  • skin itching, hives, or rash

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

• fever
• a reaction due to switching from another C5 inhibitor (type III immune complex-mediated reaction: symptoms may include skin redness, itching, or pain)
• nose and throat infection (upper respiratory tract infection). Symptoms may include runny nose, sneezing, sore throat, and cough
• infusion reactions
• headache

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

• allergic reactions (hypersensitivity)
• urinary tract infection
• lung infection
• injection site reaction
• sore throat and runny nose (nasopharyngitis)
• joint pain (arthralgia)
• abdominal pain
• diarrhoea
• extreme tiredness or weakness (asthenia)
• fatigue
• rash

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

• bacterial infection (bacteraemia)
• kidney infection (pyelonephritis)
• severe reaction to an infection (sepsis), which may be accompanied by a severe drop in blood pressure (septic shock)
• local reaction at injection site
• respiratory tract infection

Inform your doctor, pharmacist, or nurse if you notice any of the other side effects listed above. If you are unsure about what the side effects listed above mean, ask your doctor to explain them to you.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Piasky

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
vial after “Exp./EXP.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). After removal from the refrigerator, vials kept sealed in the
original packaging may be stored at room temperature (not above 30 °C) for up to 7 days. Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Do not store pre-filled syringes containing this medicine. Pre-filled syringes with Piasky must be used immediately.
Do not use this medicine if you notice it is cloudy, has changed colour, or contains particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Further details are provided in the instructions for use. Please read them carefully before using the
vial of Piasky.

6. Contents of the pack and other information

What Piasky contains

• The active substance is crovalimab. Each glass vial contains 340 mg of crovalimab in 2 mL of solution. Each mL of injectable or infusion solution contains 170 mg of crovalimab.
• The other components are histidine, aspartic acid, arginine hydrochloride, poloxamer 188, and water for injections.

Description of the appearance of Piasky and contents of the pack
Piasky is an injectable or infusion solution, from clear to markedly opalescent, and from almost colourless to brownish-yellow.
Each pack of Piasky contains 1 glass vial of 2 mL.

Marketing Authorisation Holder and Manufacturer
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

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

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 474 5444

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 1 279 4500

Danmark Malta
Roche Pharmaceuticals A/S Refer to Ireland
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: +372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp. z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Κύπρος Sverige
Roche (Hellas) A.E. Tel: Roche AB
+30 210 61 66 100 Tel: +46 (0) 8 726 1200

Latvija United Kingdom (Northern Ireland)
Roche Latvija SIA Roche Products (Ireland) Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000

Further information
More detailed information about this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

7. Instructions for Use

Before using the vial
Read all instructions for use before you or your caregiver begins using the Piasky vial,
and each time you receive a new prescription. There may be new information.
These instructions do not replace discussions with your doctor regarding your medical condition
or treatment.
Your doctor may decide that you or your caregiver may administer Piasky injections.

• In this case, your doctor or nurse will show you or your caregiver how to correctly inject the dose of Piasky.
• Do not use the Piasky vial until your doctor or nurse has trained you or your caregiver on the correct way to administer the injection.
• Do not inject the medicine into a vein (intravenous injection).

Storage and handling

• Store the Piasky vial in its original packaging in the refrigerator (2 °C to 8 °C) until ready for use. The unopened Piasky vial may be stored at room temperature not exceeding 30 °C for up to 7 days, kept in its original packaging.
• Keep the Piasky vial in its outer packaging to protect the medicine from light.
• After removing the Piasky vial from its packaging, keep Piasky away from direct sunlight.
• Keep Piasky vials, syringes, and needles out of the reach of children.
• Each Piasky vial, syringe, and needle may be used only once.
• Keep hands away from the needle tip during use and disposal.
• Do not freeze the vial. Do not use the vial if it has been frozen. Discard the vial in a sharps disposal container (see step 43) and contact your doctor or pharmacist.
• Do not use the vial if it has been stored at room temperature above 30 °C for more than 7 days. Discard the vial in a sharps disposal container (see step 43) and contact your doctor or pharmacist.
• Do not store filled syringes with Piasky. A syringe filled with medicine must be used immediately.
• Do not shake the vial.
• Do not reuse the vial, syringe, or needles for another injection.
• Do not share syringes or needles with other people.

Full dose and number of injections
Your Piasky dose may require up to 3 injections, one after the other. You may need up to 3 Piasky vials to receive the full dose.

• Your doctor or pharmacist will inform you or your caregiver how many injections to administer and how frequently to give the medicine.
• If your prescribed Piasky dose is 680 mg, administer 2 separate injections one after the other.
• If your prescribed Piasky dose is 1,020 mg, administer 3 separate injections one after the other.
• Always use a new Piasky vial for each injection.
• If you have any doubts about the dose, consult your doctor or pharmacist.
• Do not split the full dose if you do not have all the Piasky vials you need. Contact your doctor or pharmacist.

Materials needed for 1 injection
The list refers to a single injection. Adjust the quantity of materials based on the number of injections required (see the section “Full dose and number of injections” above).
Included in the package:

• 1 Piasky vial

Not included in the package:

• 18-gauge single-pointed transfer needle or standard 21-gauge needle
• 25-, 26-, or 27-gauge injection needle with safety shield. The needle should be \9 mm) to ½” (13 mm) long.
• 2 mL or 3 mL syringe
• 2 alcohol swabs (1 for skin, 1 for vial)
• 1 sterile cotton ball or gauze pad
• 1 small adhesive bandage
• 1 sharps or puncture-proof disposal container (see step 43)

Open the package

1 Remove the Piasky package(s) from the refrigerator.
Open the package(s) and remove the vial(s).
Check the dose prescribed by your doctor. Up to 3 consecutive injections may be needed for the full dose.
You may need up to 3 vials to administer a complete dose. Prepare all necessary vials.
2 Place the vial(s) on a clean, flat surface.

• Do not use the vial if the packaging is damaged or if the seal is broken. Discard the vial in a sharps disposal container (see step 43) and contact your doctor or pharmacist.

Check the vial(s)

3 Check the expiration date (EXP) on the vial(s).
4 Check the appearance of the medicine.
The medicine should be from clear to strongly opalescent, from nearly colorless to yellowish-brown.
5 Check that the vial(s) are not damaged, e.g., no cracks or scratches.

• Do not use the medicine if the expiration date (EXP) has passed.
• Do not use the medicine if it appears cloudy, discolored, or contains particles.
• Do not use the medicine if the vial is cracked or broken. If any of the above conditions are observed, discard the vial in a sharps disposal container (see step 43) and contact your doctor or pharmacist.

Warming time

30 min
6 Place the vial(s) on a clean, flat surface for 30 minutes, away from direct sunlight. This allows the medicine to reach room temperature.
If the vial is not at room temperature, the cold medicine may make withdrawal difficult and the injection more uncomfortable. It may also cause discomfort.

• Do not attempt to speed up the warming process in any way, such as using a microwave, warm water, or direct sunlight.
• Do not remove the vial cap while the vial is warming to room temperature.

Gather other materials

7 Gather the other materials while the vial reaches room temperature.
The list refers to a single injection. Adjust the quantity of materials based on the number of injections needed.
Note: the color of materials may differ from the illustrations.

• 1 transfer needle
• 1 injection needle with safety shield
• 1 syringe
• 2 alcohol swabs – 1 for skin, 1 for vial
• 1 sterile cotton ball or gauze pad
• 1 small adhesive bandage
• 1 sharps disposal container

Selecting the injection site

8 Piasky must be injected only in the stomach area (abdomen).
Ensure you do not inject repeatedly at the same site. Each injection should be given at least 5 cm away from the previous injection site.

• Do not inject in the arm or thigh.
• Do not inject within 5 cm of the navel.
• Do not inject over moles, scars, or areas where the skin is tender, bruised, red, hardened, or not intact.

Clean the injection site

9 Wash your hands with soap and water.
10 Clean the injection site with an alcohol swab and allow it to air dry.

• Do not touch, fan, or blow on the cleaned area.

Clean the vial stopper

11 Remove the colored cap from the vial. Discard the colored cap in a sharps disposal container (see step 43).
12 Clean the rubber stopper with the other alcohol swab.

• Do not touch the rubber stopper after cleaning.

Attach the transfer needle

13 Remove the syringe and transfer needle from their packaging.
14 Push and twist the transfer needle firmly onto the syringe. Keep the cap on the needle.

• Do not use the injection needle (with safety shield) to withdraw the medicine.

Fill the syringe with air

2 mL
15 With the needle cap still on, slowly pull back the plunger to draw air into the syringe up to the 2 mL mark.
Note: the vial does not contain air. Injecting air into the vial will make it easier to withdraw the medicine and prevent plunger movement.
Remove the transfer needle cap

16 Hold the syringe by the center and carefully remove the protective needle cap.
17 Place the cap on a flat surface.
You will need to replace it on the needle after transferring the medicine.

• Do not discard the cap.
• After removing the cap, do not touch the needle or let it contact any surface.

Inject air into the vial

18 Hold the vial on a flat surface and insert the needle vertically into the center of the rubber stopper.
19 Invert the vial, keeping the needle inserted.
20 Ensure the needle tip is above the medicine level.
21 With the vial held upside down, push the plunger to inject the air into the vial.
22 Keep your fingers on the plunger to prevent it from moving.

• Do not inject air into the medicine, as this may create air bubbles.

Transfer all the medicine

23 Move the needle tip downward so it is immersed in the medicine.
24 Slowly pull back the plunger to transfer all the medicine into the syringe.
Ensure the needle tip remains in the medicine during transfer. You may need to slide the needle down or transfer a small amount of air into the syringe.

• Do not completely remove the needle from the vial.
• Do not completely pull the plunger out of the syringe.

Remove air bubbles

25 If there are air bubbles or an air space in the syringe, gently tap the side of the syringe with your finger until the bubbles rise to the top.
26 Slowly push the plunger upward to expel the air bubbles back into the vial.
If some medicine is pushed back into the vial, slowly pull back the plunger (more slowly this time) to transfer all the medicine from the entire vial (see steps 23 and 24).
Replace the cap on the transfer needle

27 Remove the syringe from the vial.
28 Using one hand only, slide the needle into the cap placed on the flat surface.
29 Once the needle is covered, lift the syringe and push the cap to secure it fully over the needle.

• Do not hold the cap with your fingers while sliding the needle into it.

Warning: do not use the transfer needle to inject the medicine. The transfer needle is too large for injection.
Remove the transfer needle

30 Hold the syringe and twist the transfer needle to remove it.
31 Discard the transfer needle in a sharps disposal container (see step 43).

• Do not touch the syringe tip after removing the transfer needle.

Attach the injection needle

32 Remove the injection needle from its packaging.
33 Push and twist the injection needle firmly onto the syringe.
34 Slide the safety shield backward toward the syringe, as shown in the figure above.
Remove the injection needle cap

35 Hold the syringe by the center and carefully remove the protective needle cap.

• Do not twist or bend the cap while removing it.
• Do not touch the needle or let it contact any surface.
• Do not replace the cap after removal, as it may damage the needle.
• Do not use the syringe if it has been dropped or damaged.

Adjust the plunger

2 mL
36 Slowly push the plunger to the 2 mL mark.
Insert the needle

37 With one hand, pinch the cleaned skin area to form a skin fold.
38 With the other hand, hold the syringe by the center at a 45° to 90° angle to the skin.
39 Quickly insert the needle fully into the skin fold.

• Do not hold or press the plunger during needle insertion.

Inject the medicine

40 Slowly push the plunger all the way in to inject all the medicine.
41 Release the skin fold and remove the needle.
Cover the injection needle

“click”
42 After the injection, press the thumb against the safety shield to push it over the needle until you hear or feel a “click”. If you do not hear a “click”, check that the needle is fully covered by the safety shield.

• Do not replace the original cap on the needle.
• Do not use both hands to cover the needle.
• Do not remove the needle from the syringe.

Dispose of the syringe and vial

43 Immediately after use, place the used Piasky vial, syringe, needles, and any remaining materials into a sharps disposal container.

• Do not dispose of needles, syringes, or vials in household waste.
• Do not attempt to disassemble the syringe.

Check the injection site

44 There may be a small amount of blood or medicine at the injection site. Press a cotton ball or gauze pad on the site until bleeding stops. If needed, cover the site with a small bandage. If bleeding does not stop, contact your doctor.
The injection is now complete.

• Do not rub or massage the injection site.

Second or third injection
If your prescribed dose requires 2 or 3 consecutive injections, restart at step 8
using a new Piasky vial and new materials. Up to 3 vials may be needed for a full dose. Ensure the next injection is not given at the same site previously used.
Disposal of syringes and vials
Do not dispose of any medicine in wastewater or household trash.

Ask your pharmacist how to properly dispose of unused medicines. This helps protect the environment.
When the container is full, ensure it is disposed of according to instructions from your doctor, nurse, or pharmacist.