STOBOCLO 60 mg /Ml Injectable Solution In Pre-Filled Syringe

Зміст інструкції

1. Stoboclo 60 mg injectable solution in pre-filled syringe
   1. What Stoboclo is and what it is used for
   2. What you need to know before you use Stoboclo
   3. How to use Stoboclo
   4. Possible side effects
   5. How to store Stoboclo
   6. Package Contents and Other Information
   7. Gather the injection materials.
   8. Check the expiration date on the box (see
   9. Remove the pre-filled syringe from the box.
   10. Inspect the pre-filled syringe.
   11. Inspect the medicine.
   12. Wait 30 minutes.
   13. Choose an appropriate injection site (see Figure H).
   14. Wash your hands.
   15. Clean the injection site.
   16. Remove the cap.
   17. Insert the pre-filled syringe into the injection site.
   18. Perform the injection.
   19. Remove the pre-filled syringe from the injection site
   20. Injection site care.
   21. Dispose of the pre-filled syringe.

Stoboclo 60 mg injectable solution in pre-filled syringe

denosumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start to use 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Your doctor will give you a patient reminder card containing important safety information that you need to know before and during treatment with Stoboclo.

Contents of this leaflet

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

1. What Stoboclo is and what it is used for

What Stoboclo is and how it works
Stoboclo contains denosumab, a protein (monoclonal antibody) that interferes with the action of
another protein, for the treatment of bone loss and osteoporosis. Treatment with Stoboclo
makes bones stronger and less likely to fracture.
Bone is a living tissue that is constantly being renewed. Estrogens help to keep bones
healthy. After menopause, a decrease in estrogen levels can make bones thin and fragile, which
can lead to the development of a condition called osteoporosis. Osteoporosis can also
occur in men for various reasons including aging and/or a low
level of the male hormone, testosterone. It can also occur in patients receiving
glucocorticoids. Many patients with osteoporosis do not have symptoms, but are still at
risk of bone fractures, especially in the spine, hip and wrists.
Surgical procedures or medications that stop the production of estrogen or testosterone,
used to treat patients with breast or prostate cancer, can also cause
bone loss. Bones thus become more fragile and fracture more easily.

What type of treatment Stoboclo is used for
Stoboclo is used for the treatment of:

• osteoporosis in women after menopause (postmenopausal osteoporosis) and in men who have an increased risk of fractures (broken bones), to reduce the risk of vertebral, non-vertebral and hip fractures.

• bone loss in men resulting from a decrease in hormone (testosterone) levels due to surgery or drug therapy in patients with prostate cancer.
• bone loss due to long-term treatment with glucocorticoids in patients at increased risk of fracture.

2. What you need to know before you use Stoboclo

Do not use Stoboclo

• if you have reduced levels of calcium in the blood (hypocalcemia).
• if you are allergic to denosumab or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Stoboclo.
During treatment with Stoboclo you may develop a skin infection with symptoms such as
swelling, redness, most commonly in the lower leg, with a feeling of warmth and
pain (cellulitis) and with possible feverish symptoms. Tell your doctor immediately if you
experience any of these symptoms.
During treatment with Stoboclo you must also take calcium and vitamin D supplements. Your
doctor will discuss this with you.
During treatment with Stoboclo you may have low levels of calcium in the blood. Tell your
doctor immediately if you notice any of the following symptoms: spasms, contractions or cramps in the
muscles, and/or numbness or tingling in the fingers, toes or around the mouth, and/or
convulsions, confusion or loss of consciousness.
In rare cases, severely low levels of calcium in the blood have been reported, which have led to
hospitalization and even life-threatening reactions. Before each dose and in patients
prone to developing hypocalcemia within two weeks of the initial dose, blood calcium levels will therefore be checked (by blood test).
Tell your doctor if you suffer from or have ever suffered from severe kidney problems, kidney impairment or if you
have been undergoing dialysis or are taking medicines called glucocorticoids (such as prednisolone or
dexamethasone), which could increase your risk of having low levels of calcium in the blood if you do not
take calcium supplements.
Problems with the mouth, teeth or jaw/jawbone
An undesirable effect called osteonecrosis of the jaw/jawbone (severe degeneration of the
bone tissue of the jaw/jawbone) has been reported rarely (may occur in up to 1 in 1,000 patients) in patients receiving denosumab for osteoporosis. The risk of osteonecrosis of the
jaw/jawbone increases in patients treated for a long period (may occur in up to 1
in 200 patients if treated for 10 years). Osteonecrosis of the jaw/jawbone can also occur
even after treatment has been stopped. It is important to try to prevent the development of osteonecrosis
of the jaw/jawbone as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the
jaw/jawbone, take the following
precautions:
Before receiving treatment, tell your doctor or nurse (healthcare professional) if you:

• have any problems with your mouth or teeth, such as poor dental hygiene, gum problems, or are planning to have a tooth extracted;
• do not undergo regular dental care or have not had a dental check-up for a long period;
• are a smoker (as this can increase the risk of dental problems);
• have been previously treated with a bisphosphonate (used to treat or prevent bone disorders);
• are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
• have cancer.

Your doctor may ask you to have a dental check-up (by a dentist) before starting
treatment with Stoboclo.
During treatment, it is necessary to maintain good oral hygiene and undergo periodic dental
check-ups. If you wear dentures, you must ensure that they fit properly. If
you are undergoing dental treatment or are planning to have dental surgery (e.g. tooth extractions), tell your doctor about the dental treatment and tell your dentist that you are in
treatment with Stoboclo.
Contact your doctor and dentist immediately if you notice the appearance of problems with your mouth or teeth
such as tooth loss, pain or swelling or failure to heal mouth sores or the presence of
discharge, as these may be signs of an undesirable effect called osteonecrosis of the
jaw/jawbone.
Atypical femoral fractures
Some people have developed atypical fractures of the femur during treatment with denosumab.
Contact your doctor if you experience new or unusual pain in the hip, groin or thigh.

Children and adolescents
Stoboclo should not be used in children and adolescents under the age of 18 years.

Other medicines and Stoboclo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. It is particularly important that you tell your doctor if you are taking other
medicines that contain denosumab.
You must not take Stoboclo together with other medicines that contain denosumab.

Pregnancy and breastfeeding
Stoboclo has not been studied in pregnant women. It is important that you tell your doctor if you are
pregnant; if you think you might be pregnant; or if you are planning a
pregnancy. The use of Stoboclo is not recommended if you are pregnant. Women of childbearing potential
must use effective contraceptive methods while taking Stoboclo and for at least 5 months after
stopping treatment with Stoboclo.
If you become pregnant during treatment with Stoboclo or within 5 months after stopping
treatment with Stoboclo, please inform your doctor.
It is not known whether denosumab passes into breast milk. It is important that you tell your doctor if you are
breastfeeding or are planning to breastfeed. Your doctor will then help you decide whether to stop
breastfeeding or taking Stoboclo, considering the benefit of breastfeeding for the baby
and the benefit of taking Stoboclo for the mother.
If you are breastfeeding during treatment with Stoboclo, tell your doctor.
Ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Stoboclo does not alter or negligibly alters the ability to drive vehicles or use machines.

Stoboclo contains sorbitol (E420)
This medicine contains 47 mg of sorbitol per mL of solution.

Stoboclo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 60 mg, i.e. essentially ‘sodium-free’.

Stoboclo contains polysorbate 20 (E432)
This medicine contains 0.1 mg of polysorbate 20 per syringe, equivalent to 0.1 mg/L. Polysorbates
can cause allergic reactions. Tell your doctor if you have known allergies.

3. How to use Stoboclo

The recommended dose is one pre-filled syringe of 60 mg administered once every 6 months, as a
single injection under the skin (subcutaneous). The most suitable injection sites are the upper
thighs and the abdomen. If someone is assisting you with the injection, they can also use the upper
outer part of the arm. Consult your doctor regarding the date of the possible next injection.
Each pack of Stoboclo contains a reminder card included in the box and used to keep
track of the date of the next injection.
During treatment with Stoboclo, you must also take calcium and vitamin D supplements. Your
doctor will discuss this with you.
Your doctor may decide whether it is better for you or the person assisting you to administer the injection with
Stoboclo. Your doctor or nursing staff will show you or the person assisting you how to
use Stoboclo. For instructions on how to inject Stoboclo, refer to the paragraph at the end of this leaflet.
Do not shake.

If you forget to take Stoboclo
If you have forgotten a dose of Stoboclo, the injection should be given as soon as possible.
Subsequently, the injections must be given every 6 months from the date of the last injection.

If you stop taking Stoboclo
To get the maximum benefit from treatment in reducing the risk of fractures, it is important
to take Stoboclo for the entire period prescribed by your doctor. Do not stop treatment without
consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not uncommonly, patients treated with Stoboclo may develop skin infections
(especially cellulitis). Tell your doctor immediatelyif you experience any of these
symptoms while taking Stoboclo: appearance of redness and swelling of the skin, more
commonly in the lower leg, with a feeling of warmth and pain and with possible
feverish symptoms.
Rarely, patients treated with Stoboclo may develop pain in the mouth and/or
jaw/mandible, swelling or sores that do not heal in the mouth or
jaw/mandible, presence of discharge, numbness or feeling of heaviness in the
jaw/mandible, or loosening of a tooth. These could be signs of a serious
degeneration of the bone tissue of the jaw/mandible (osteonecrosis). Tell your doctor and
dentist immediatelyif you experience such symptoms during treatment with Stoboclo or after stopping
treatment.
Rarely, patients treated with Stoboclo may have low levels of calcium in the blood
(hypocalcemia); severely low levels of calcium in the blood can lead to hospitalization and
be life-threatening. Symptoms include spasms, contractions or cramps of muscles, and/or
numbness or tingling in the fingers of the hands, feet or around the mouth and/or convulsions,
confusion, or loss of consciousness. Tell your doctor immediatelyif any of these
symptoms occur. Low levels of calcium in the blood can also lead to a change in heart rhythm
called prolongation of the QT interval, which is detected by electrocardiogram (ECG).
Rarely, atypical fractures of the femur can occur in patients treated with Stoboclo.

Contact your doctorif you experience new or unusual pain in the hip, groin or thigh, as
this could be an early sign of a possible femur fracture.
Rarely, allergic reactions can occur in patients treated with Stoboclo. Symptoms
include swelling of the face, lips, tongue, throat or other parts of the body; rash,
itching, hives, wheezing or difficulty breathing. Tell your doctorif you experience any
of these symptoms while being treated with Stoboclo.

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

• bone, joint and/or muscle pain, sometimes severe,
• pain in the arms or legs (limb pain).

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

• frequent and painful urination, blood in the urine, urinary incontinence,
• upper respiratory tract infections,
• pain, tingling or numbness radiating to the lower limbs (sciatica),
• constipation,
• abdominal discomfort,
• rash,
• itching, redness and/or dryness of the skin (eczema),
• hair loss (alopecia).

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

• fever, vomiting and abdominal pain or abdominal disorders (diverticulitis),
• ear infections,
• rash that may occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions).

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

• allergic reaction that can damage blood vessels mainly at the level of the skin (e.g. purple or brownish-red spots, hives or skin ulcers) (hypersensitivity vasculitis).

Not known(frequency cannot be estimated from available data):

• tell your doctor if you experience ear pain, ear discharge, and/or an ear infection. These could be signs of damage to the ear bone.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system indicated
in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Stoboclo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the pack after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
The pre-filled syringe can be left out of the refrigerator in such a way as to reach
room temperature (up to 25 °C) before injection. This will make the injection more comfortable.
Once the syringe has reached room temperature (up to 25 °C), it must be used
within 1 month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Stoboclo contains

• The active ingredient is denosumab. Each 1 mL pre-filled syringe contains 60 mg of denosumab (60 mg/mL).
• The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol (E420), polysorbate 20 (E432) and water for injections.

Description of Stoboclo and package contents
Stoboclo is a clear, injectable solution, from colourless to pale yellow, in a pre-filled syringe
ready for use.
Each pack contains one pre-filled syringe with a safety protector.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France S.A.R.L
2400 Route des Colles,
Biot, 06410
France

Manufacturer
Midas Pharma GmbH
Rheinstrasse 49, West,
Ingelheim Am Rhein,
Rhineland-Palatinate, 55218
Germany

Manufacturer
Kymos S.L.
Ronda de Can Fatjó, 7B
Parc Tecnològic del Vallès,
Cerdanyola del Vallès,
Barcelona, 08290
Spain
For further information on this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418
[email protected]

Lietuva
EGIS PHARMACEUTICALS PLC atstovybė
Tel: +370 5 231 4658

България
EGIS Bulgaria EOOD
Teл.: + 359 2 987 6040

Luxembourg/Luxemburg
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418
[email protected]

Česká republika
EGIS Praha, spol. s r.o
Tel: + 420 227 129 111

Magyarország
Egis Gyógyszergyár Zrt.
Tel.: + 36 1 803 5555

Danmark
Celltrion Healthcare Denmark ApS
Tlf.: +45 3535 2989
[email protected]

Malta
Mint Health Ltd
Tel: +356 2093 9800

Deutschland
Celltrion Healthcare Deutschland GmbH
Tel: +49 (0)30 346494150
i [email protected]

Nederland
Celltrion Healthcare Netherlands B.V.
Tel: + 31 20 888 7300
[email protected]

Eesti
Celltrion Healthcare Hungary Kft.
[email protected]

Norge
Celltrion Healthcare Norway AS
[email protected]

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30 210 8009111 - 120

Österreich
Astro-Pharma GmbH
Tel: +43 1 97 99 860

España
CELLTRION FARMACEUTICA (ESPAÑA)
S.L.
Tel: +34 919 94 23 90

Polska
EGIS Polska Sp. z o.o.
Tel.: + 48 22 417 9200

France
Celltrion Healthcare France SAS
Tél.: +33 (0)1 71 25 27 00

Portugal
CELLTRION PORTUGAL, UNIPESSOAL LDA
Tel: +351 21 936 8542

Hrvatska
Oktal Pharma d.o.o.
Tel: +385 1 6595 777

România
Egis Pharmaceuticals PLC Romania
Tel: + 40 21 412 0017

Ireland
Celltrion Healthcare Ireland Limited
Tel: +353 1 223 4026
[email protected]

Slovenija
OPH Oktal Pharma d.o.o.
Tel.: +386 1 519 29 22

Ísland
Celltrion Healthcare Hungary Kft.
[email protected]

Slovenská republika
EGIS SLOVAKIA spol. s r.o
Tel: +421 2 3240 9422

Italia
Celltrion Healthcare Italy S.R.L.
Tel: +39 0247927040
[email protected]

Suomi/Finland
Celltrion Healthcare Finland Oy.
Puh/Tel: +358 29 170 7755
[email protected]

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741741

Sverige
Celltrion Healthcare Hungary Kft.
[email protected]

Latvija
EGIS Pharmaceuticals PLC pārstāvniecība
Latvijā
Tel: +371 67613859

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency: https://www.ema.europa.eu/
---------------------------------------------------------------------------------------------------------------------------

Instructions for use:
Read and follow the instructions for use provided with the pre-filled syringe of Stoboclo before
starting to use it and each time you receive a new supply. There may be new information.
Stoboclo can be administered by healthcare professionals, caregivers or can be self-administered by
patients if they have received appropriate training. Consult your doctor if you have questions
about self-administering an injection.

Important information

• Stoboclo is administered as an injection into the tissue just below the skin (subcutaneous injection).
• Do notopen the sealed pack until you are ready to use the pre-filled syringe.
• Do notremove the needle cap from the pre-filled syringe until the time of injection.
• Do nottry to activate the pre-filled syringe before the injection.
• Do nottry to remove the transparent safety shield from the pre-filled syringe.
• Do notuse the pre-filled syringe if it has fallen onto a hard surface. Use a new pre-filled syringe.
• Do notshake the pre-filled syringe. Vigorous shaking may damage the medicine.
• The pre-filled syringe cannot be reused. Dispose of the used pre-filled syringe immediately after use in a sharps disposal container (see Step 15. Disposing of Stoboclo).

Storing Stoboclo

• Keep the pre-filled syringe out of the sight and reach of children; it containssmall parts.
• Store the pre-filled syringe in a refrigerator at a temperature between 2 °C and 8 °C. Do notfreeze it.
• Once removed from the refrigerator, Stoboclo should not be exposed to temperatures above 25 °C. Stoboclo must be stored in its original packaging and used within 30 days. If not used within 1 month, Stoboclo must be discarded.
• Store the pre-filled syringe sealed inside its packaging to protect it from light.

Parts of the pre-filled syringe (see Figure A)

Before useAfter use
Figure A
Preparing the injection

1. Gather the injection materials.

1a. Prepare a clean, flat surface, such as a table or
countertop, in a well-lit area.
1b. Remove the box containing the pre-filled syringe from the refrigerator.
1c. Make sure you have the following materials (see Figure B):

• Box containing the pre-filled syringe Not included in the box:
• Alcohol swab
• Cotton ball or gauze
• Adhesive bandage
• Sharps disposal container

Figure B

2. Check the expiration date on the box (see

Figure C).

• Do notuse if the expiration date has passed. If the expiration date has passed, return the entire box to the pharmacy.
• The expiration date printed refers to the last day of the month.

Figure C

3. Remove the pre-filled syringe from the box.

3a. Open the box. Grasping the body of the pre-filled syringe, lift it from the box (see Figure D).

• Do notgrasp the plunger head, the plunger, the safety guard, the fins or the needle cap.
• Do notpull back the plunger at any time.

Figure D
Preparing the injection

4. Inspect the pre-filled syringe.

4a. Observe the pre-filled syringe and ensure that it contains the correct medication (Stoboclo).
4b. Observe the pre-filled syringe and ensure that it is not cracked or damaged.
4c. Check the expiration date on the label of the pre-filled syringe (see Figure E).

• Do notuse it if the needle cap is missing or is not securely attached.
• Do notuse it if the expiration date has passed.
• Do notshake the pre-filled syringe .

Figure E

5. Inspect the medicine.

5a. Observe the medicine and confirm that the liquid is transparent, from colorless to pale yellow and that it does not contain any visible particles or flocculi (see Figure F).

• Do notuse the pre-filled syringe if the liquid has changed color, is cloudy, or contains visible particles or flocculi.
• The presence of air bubbles in the liquid is normal.

Figure F

6. Wait 30 minutes.

6a. Leave the pre-filled syringe out of the box for
30 minutes at room temperature (from 20 °C to 25 °C) to allow it to
warm up (see Figure G).

30
minutes

• Do notheat the pre-filled syringe using heat sources such as hot water or a microwave oven.
• If the syringe does not reach room temperature, the injection may be uncomfortable.

Figure G
Preparing the injection

7. Choose an appropriate injection site (see Figure H).

7a. The injection can be performed:

ONLY caregivers and
healthcare professionals- in the upper part of the thighs

• in the abdomen, except within 5 cm around the navel
• in the outer area of the upper arms (only if performed by a caregiver or healthcare professional).
• Do notinject into moles, scars, bruises or areas where the skin is sore, red, hardened or if there are cracks in the skin.
• Do notinject through clothing. 7b. Choose a different inoculation site for each new injection, at least 2.5 cm away from the area used for the last injection. Self-injectionand caregivers

Figure H

8. Wash your hands.

8a. Wash your hands with water and soap and dry them thoroughly
(see Figure I).

Figure I

9. Clean the injection site.

9a. Clean the injection site with a swab soaked in alcohol
making a circular motion (see Figure J).
9b. Allow the skin to dry before administering the injection.

• Do notblow on or touch the injection site again before administering the injection.

Figure J
Injection administration

10. Remove the cap.

10a. Hold the body of the pre-filled syringe in one hand, between your thumb and index finger. With the other hand, carefully remove the needle cap immediately afterwards (see Figure K).

• Do notgrip the plunger rod while removing the cap.
• You may notice a drop of liquid on the needle tip. This is normal. 10b. Immediately dispose of the cap in a sharps disposal container (see Step 15and Figure K).
• Do notuse the pre-filled syringe if it has been dropped without the needle cap. If this happens, use a new pre-filled syringe.
• Remove the needle cap only when you are ready for the injection.
• Do notreplace the cap on the pre-filled syringe.
• Do nottouch the needle. This could cause an injury from Figure K

needle stick.

11. Insert the pre-filled syringe into the injection site.

11a. Hold the body of the pre-filled syringe with one hand
between the thumb and index finger.
11b. Use the other hand to gently pinch the clean skin
between the thumb and index finger. Do notsqueeze tightly.
Note: it is important to keep the skin pinched when inserting the
needle to ensure injection under the skin (into the
fatty tissue) but not deeper (into the muscle).
11c. With a quick and decisive movement, insert
the needle completely into the skin fold at a 45
degree angle (see Figure L).

45°
OR

• Never pull back the plunger.45°

Figure L
Administration of the injection

12. Perform the injection.

12a. After inserting the needle, release the skin fold.
12b. Slowly push the plunger rod all the way down
to inject the entire dose of the medicine and empty
the syringe completely (see Figure M).

• Do notchange the position of the pre-filled syringe after starting the injection.
• If the plunger rod is not pressed all the way down, the safety shield will not extend to cover the needle when it is removed.

Figure M

13. Remove the pre-filled syringe from the injection site

13a. After emptying the pre-filled syringe, remove
the needle slowly by lifting your thumb from the plunger until
the needle is completely covered by the safety shield (see Figure N).

• If the needle is not covered, carefully dispose of the syringe (see Step 15, Dispose of Stoboclo).
• Do notreplace the needle cap on the used pre-filled syringe.
• Do notreuse the pre-filled syringe.
• Do notrub the injection site.

Figure N
After the injection

14. Injection site care.

14a. If bleeding occurs, treat the injection site by gently pressing a cotton ball or gauze on the site without rubbing, and apply an adhesive bandage if necessary.

After the injection

15. Dispose of the pre-filled syringe.

15a. Immediately after use, place the used pre-filled syringe in a sharps disposal container (see

Figure O).
15b. Do notdiscard (dispose of) the pre-filled syringe in household waste.

• Keep the syringe and the sharps disposal container out of the sight and reach of children.
• If you do not have a sharps disposal container, you can use a resealable, puncture-resistant household container.
• For your own safety and the safety of others, used needles and syringes should never be reused. Unused medicine and waste medicine must be disposed of in accordance with local regulations.
• Do notdispose of any medicine down the drain or in household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Figure O