SONDELBAY INJECTION 20 MCG80 MCL

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Teriparatide

Boleh didapati daripada:

ACCORD HEALTHCARE PRIVATE LIMITED

Kod ATC:

H05AA02

Borang farmaseutikal:

INJECTION, SOLUTION

Komposisi:

Teriparatide 20 mcg/80μl

Laluan pentadbiran:

SUBCUTANEOUS

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

Intas Pharmaceuticals Limited Biopharma Division

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2023-06-01

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only. Do not pass it on to
others.
It may harm them, even if their signs of illness are the same as
yours.
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If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Sondelbay is and what it is used for
2. What you need to know before you use Sondelbay
3. How to use Sondelbay
4. Possible side effects
5. How to store Sondelbay
6. Contents of the pack and other information
1. WHAT SONDELBAY IS AND WHAT IT IS USED FOR
Sondelbay contains the active substance teriparatide that is used to
make the
bones stronger, and to reduce the risk of fractures by stimulating
bone
formation.
Sondelbay is used to treat osteoporosis in men and postmenopausal
women
who are at high risk for fracture. Osteoporosis is a disease that
causes your
bones to become thin and fragile. This disease is especially common in
women
after the menopause, but it can also occur in men. Osteoporosis is
also
common in patients receiving corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SONDELBAY
DO NOT USE SONDELBAY
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if you are allergic to teriparatide or any of the other ingredients of
this
medicine (listed in section 6).
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if you suffer from high calcium levels (pre-existing hypercalcaemia).
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if you have ever been diagnosed with bone cancer or other cancers that
have spread(metastasised) to your bones.
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if you have certain bone diseases. If you have a bone disease, tell
your
doctor.
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if you have unexplained high levels of alkaline phosphatase in your
blood, which means you might have Paget’s disease of bone (disease
with abnormal bone changes). If you are not sure, ask your doctor.
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if you have ha

Ciri produk

90°
Pull off the pen cap.
HOLD FOR
5 SECONDS
Let go of the dose setting dial. The
filled circle with a bar above it will
be seen in the dose setting window.
This confirms you have set your dose.
CHECK that an empty
circle sign is in the
dose setting window.
PREPARE
ATTACH
NEW NEEDLE
2
SET
DOSE
3
INJECT
DOSE
4
CONFIRM
DOSE
5
REMOVE
NEEDLE
6
1
TURN THE PAGE FOR MORE INFORMATION
Push the needle STRAIGHT
onto the medicine cartridge.
Obtain a new pen needle (see above).
Pull off the paper tab.
SCREW on the needle until FIRMLY attached.
Pull off the large needle cover and SAVE IT.
You will need it to remove the needle after use.
TURN the dose setting dial firmly
clockwise, arrows will be seen in
the dose setting window.
Keep turning all the way until you
hear a click and see a FILLED CIRCLE
SIGN in the dose setting window.
PULL OFF the small needle
protector and DISPOSE OF IT.
Gently hold a fold of skin from the thigh or abdomen.
Insert the needle straight into the skin, making sure
that the DOSE SETTING WINDOW IS VISIBLE to you.
Put the large needle cover on the needle as shown
above, then PUSH it to secure it in place. To prevent
needlestick injuries, DO NOT try to re-attach the small
needle protector or touch the needle.
Unscrew the needle from the pen by
rotating the large needle cover
counter-clockwise at least 5 times.
PULL OFF the needle and dispose of it as
directed by your doctor or pharmacist.
Push the pen cap back on the
pen firmly. Store the pen in the
REFRIGERATOR immediately after use.
AFTER YOU HAVE COMPLETED THE INJECTION
and removed the needle from the skin,
CHECK to make sure that the empty circle
sign appears in the dose setting window.
Keep the needle in the skin, SLIDE the injection
button until it stops. This will start your injection.
Keep the needle in the skin, wait until an empty
circle sign appears in the dose setting window. Now
COUNT TO 5 SLOWLY then pull the needle from the skin.
• DO NOT INJECT A SECOND TIME ON THE SAME DAY.
• Instead, you must reset the pen.
See Troubleshooting - Pr