TERIPARATIDE 20 MIKROGRAMÓW/80 MIKROLITRÓW Roztwór do wstrzykiwań w penie wstępnie napełnionej

Treść ulotki

1. Teriparatide Ambio Pharma 20 micrograms / 80 microliters, injectable solution in pen
2. teriparatide
   1. What is Teriparatide Ambio Pharma and what is it used for
   2. What you need to know before using Teriparatide Ambio Pharma
   3. How to use Teriparatide Ambio Pharma
   4. Possible side effects
   5. How to store Teriparatide Ambio Pharma
   6. Package Contents and Other Information
   7. REMOVE THE WHITE CAP
   8. INSERT THE NEW NEEDLE
   9. SET THE DOSE
   10. INJECT THE DOSE
   11. CONFIRM THE DOSE
   12. REMOVE THE NEEDLE
   13. If you have already given the injection, DO NOT repeat

Teriparatide Ambio Pharma 20 micrograms / 80 microliters, injectable solution in pen

pre-filled
Generic medicine

teriparatide

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 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Teriparatide Ambio Pharma and what is it used for

Teriparatide Ambio Pharma contains the active substance teriparatide which is used to make bones stronger and
reduce the risk of fractures by stimulating bone rebuilding.
Teriparatide Ambio Pharma is used to treat osteoporosis in adults. Osteoporosis is a disease
that causes bones to become thin and fragile. This disease is particularly common in women after
menopause, but can also occur in men. Osteoporosis is also common in patients undergoing
treatment with corticosteroids.

2. What you need to know before using Teriparatide Ambio Pharma

• Do not useTeriparatide Ambio Pharma if you are allergic to teriparatide or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium or if you have previously had high levels of calcium.
• if you suffer from severe kidney problems.
• if you have ever been diagnosed with bone cancer or other cancers that have spread (have metastasized) to the bones.
• if you have other bone diseases. If you have a bone disease, tell your doctor.
• if you have high levels of alkaline phosphatase in your blood of unknown origin, this means you may have Paget's disease of the bone (a disease with abnormal bone changes). If you are not sure, ask your doctor.
• if you have undergone radiation therapy involving the bones.
• if you are pregnant or breastfeeding. Warnings and precautionsTeriparatide Ambio Pharma can cause an increase in the amount of calcium in the blood or urine. Talk to your doctor or pharmacist before or during taking Teriparatide Ambio Pharma:
• if you continuously experience nausea, vomiting, constipation, low energy or muscle weakness. These may be signs that there is too much calcium in the blood.
• if you suffer from kidney stones or if you have had experiences of kidney stones
• if you suffer from kidney problems (moderate renal impairment) Some patients experience dizziness or an acceleration of the heartbeat after taking the first doses. During the administration of the first doses, inject Teriparatide Ambio Pharma in a place where, if you feel dizzy, you can sit or lie down. The recommended treatment period of 24 months should not be exceeded. Teriparatide Ambio Pharma should not be used in adults in the growth phase. Children and adolescentsTeriparatide Ambio Pharma should not be used in children and adolescents (under 18 years of age).

Other medicines and Teriparatide Ambio Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally these can interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).

Pregnancy and breastfeeding
Do not use Teriparatide Ambio Pharma if you are pregnant or if you are breastfeeding with breast milk. If you are a woman of childbearing potential, you should use effective methods of contraception during the use of Teriparatide Ambio Pharma. In case of pregnancy, Teriparatide Ambio Pharma should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Some patients may experience dizziness after the injection of Teriparatide Ambio Pharma. If you feel dizzy, do not drive and do not use machines until you feel better.

Teriparatide Ambio Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Teriparatide Ambio Pharma

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
The recommended dose is 20 micrograms administered once a day via injection under the skin
(subcutaneous injection) in the thigh or abdomen. To help you remember to take the medicine, inject it
every day at the same time.
Your doctor will ensure that you receive training on how to use the pen.
Inject Teriparatide Ambio Pharma every day for the entire period of time prescribed by your doctor.
The total duration of treatment with Teriparatide Ambio Pharma should not exceed 24 months. You should not
receive more than one treatment lasting 24 months during your lifetime.
Teriparatide Ambio Pharma can be injected at mealtimes.
Read the user manual, which is included in the package, for instructions on how to use the Teriparatide Ambio Pharma pen.
Injection needles are not included in the pen package. You can use injection needles for pens
from Becton, Dickinson and Company.
You should inject Teriparatide Ambio Pharma shortly after taking the pen out of the
refrigerator as described in the user manual. After use, immediately return the pen to the
refrigerator. Use a new needle for each injection and dispose of it each time after use. Never store the
pen with the needle inserted. Never share your Teriparatide Ambio Pharma pen with other people.
Your doctor may advise you to take Teriparatide Ambio Pharma with calcium and vitamin D. Your doctor will tell you
how much calcium and vitamin D you need to take each day.
Teriparatide Ambio Pharma can be taken independently of meals.

If you use more Teriparatide Ambio Pharma than you should
If you have accidentally used more Teriparatide Ambio Pharma than you should, contact your doctor or pharmacist.
The effects of an overdose that might be expected include nausea, vomiting, dizziness and
headache.

If you forget or are unable to take Teriparatide Ambio Pharma at the time you usually do,take it
during the day as soon as possible. Do not take a double dose to make up for a missed dose. Do not give yourself more than one injection on the same day. Do not try to make up for a missed dose.

If you stop taking Teriparatide Ambio Pharma
If you are thinking of stopping treatment with Teriparatide Ambio Pharma, we invite you to discuss this with
your doctor.
Your doctor will advise you and decide how long you should be treated with Teriparatide Ambio Pharma.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are pain in the limbs (the frequency is very common, may affect more than
1 in 10 people) and feeling of nausea, headache and dizziness (the frequency is common).
If you feel dizzy after the injection, you should sit or lie down until you feel better. If
you do not feel better, you should call a doctor before continuing treatment. Cases of fainting have
been reported in association with the use of teriparatide.
If you experience discomfort as well as redness of the skin, pain, swelling, itching, a small
bruise localized or minor bleeding around the injection area (the frequency is common),
this should resolve within a few days or weeks. Otherwise, inform your doctor as soon as possible.
Some patients have experienced allergic reactions shortly after the injection, including
shortness of breath, facial swelling, rash and chest pain (the frequency is rare). In rare cases, severe and potentially life-threatening allergic reactions including anaphylaxis may
occur.
Other side effects include:
Common: may affect up to 1 in 10 people

• increased cholesterol levels in the blood
• depression
• neuralgic leg pain
• feeling of weakness
• irregular heartbeats
• shortness of breath
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• decreased blood pressure
• heartburn (a feeling of pain or burning just below the breastbone)
• feeling unwell (vomiting)
• the presence of a hernia of the channel leading food into the stomach
• decreased hemoglobin or number of red blood cells (anemia) Uncommon: may affect up to 1 in 100
• increased heart rate
• abnormal heart sounds
• labored breathing
• hemorrhoids
• involuntary loss or leakage of urine
• increased need to eliminate fluids
• weight gain
• kidney stones
• muscle pain and joint pain. Some patients have experienced severe cramps or back pain that required hospitalization.
• increased calcium levels in the blood
• increased uric acid levels in the blood
• increased levels of an enzyme called alkaline phosphatase Rare: may affect up to 1 in 1,000
• reduced kidney function, including kidney impairment
• appearance of swelling, especially in the hands, feet and legs

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Teriparatide Ambio Pharma

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 package and on the pen after Exp. The
expiry date refers to the last day of that month.
Teriparatide Ambio Pharma must always be stored in a refrigerator (from 2°C to 8°C). You can use
Teriparatide Ambio Pharma for up to 28 days after the first injection, during this period the pen is
stored in a refrigerator (2°C-8°C).
Do not freeze. Avoid placing the pens near the ice compartment in the refrigerator to prevent freezing. Do not use Teriparatide Ambio Pharma if it is or has been frozen.
After 28 days, each pen must be disposed of appropriately, even if it is not completely
empty.
Teriparatide Ambio Pharma contains a colorless and clear solution. Do not use Teriparatide Ambio Pharma
if you notice the presence of solid particles or if the solution appears cloudy or colored.
Do not dispose of any medicine in drain water and 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 the medicine containsTeriparatide Ambio Pharma
The active ingredient is teriparatide. Each millilitre of injectable solution contains 250 micrograms of
teriparatide.

• Each dose of 80 microlitres contains 20 micrograms of teriparatide.
• The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol and water for injections. In addition, hydrochloric acid solution and/or sodium hydroxide solution may have been added for pH adjustment.

Description of Teriparatide Ambio Pharma and package contents
Teriparatide Ambio Pharma is a colourless and clear solution. It is supplied in a cartridge contained in
a pre-filled pen. Each pen contains 2.4 ml of solution sufficient for 28 doses. Each pack
contains one pen.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

AMBIO PHARMA EUROPE LIMITED
3RD FLOOR ULYSSES HOUSE,
FOLEY STREET,
DUBLIN 1,
DUBLIN
IRELAND

Manufacturer:
Viatris Santé, 1 rue de Turin, 69007 Lyon, France
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder.

USER MANUAL FOR THE PEN
Teriparatide Ambio Pharma 20 micrograms / 80 microlitres, injectable solution in pre-filled
pen
INSTRUCTIONS FOR USE
Before using the new pen, read theInstructions for Useparagraph completely. Follow
the instructions carefully when you need to use the pen.
Do not share the pen or needles as there may be a risk of transmitting infectious agents.
The pen contains a quantity of medicine for 28 days.

Ask your doctor or pharmacist which gauge and length of needle are most suitable for you.
ALWAYS WASH YOUR HANDS BEFORE EACH INJECTION. PREPARE THE INJECTION SITE
FOLLOWING THE INSTRUCTIONS OF YOUR DOCTOR OR PHARMACIST.

1. REMOVE THE WHITE CAP

2. INSERT THE NEW NEEDLE

3. SET THE DOSE

4. INJECT THE DOSE

5. CONFIRM THE DOSE

IMPORTANT

6. REMOVE THE NEEDLE

Teriparatide Ambio Pharma 20
micrograms / 80 microliters, solution
for injection in a prefilled pen
TROUBLESHOOTING

ProblemSolution
TROUBLESHOOTING

• A.The yellow band isTo prime the pen, follow the steps below:

still visible after
I pressed the
black injection
button.

1. If you have already given the injection, DO NOT repeat

the injection a second time on the same
day.
How can I reset
my pen?2. Remove the needle.

• 3. Insert a new needle, remove the large needle cover and keep it.
• 4. Pull out the black injection button until it stops. Make sure the red strip is visible.
• 5. Remove the small needle protection and throw it away.
• 6.Point the needle downwards into an empty container. Press the black injection button until it stops. Keep it pressed and count slowly to 5. A small stream or drop of liquid should appear. When you are finished, theblack injection button must bepressed all the way down.
• 7. If the yellow band is still visible, contact your doctor or pharmacist.
• 8. Place the large needle cover on the needle. Unscrew the needle all the way, turning the large needle cover 3 to 5 full turns. Remove the needle and dispose of it according to your doctor's or pharmacist's instructions. Replace the white cap on the pen and store the pen in the refrigerator. You can avoid this problem by always using a NEW needle for each injection, pressing theblack injection button all the way down and counting slowly to 5.

TROUBLESHOOTING
ProblemSolution

• B. How can I checkif my penis working?The pen is designed to inject the entire dose each time it is used according to the instructions described in the Instructions for Usesection. The black injection button will appear pressed all the way down, indicating that the entire dose of the pen has been injected. Remember to use a new needle each time you give the injection to ensure the pen works properly.

• C. There is an airbubble visible in my pen.A small air bubble will not change the dose, nor will it be dangerous. You can continue to take the dose as usual.

• D. I cannot remove1. Place the large needle cover on the needle. the needle.
• 2. Use the large needle cover to unscrew it.
• 3. Unscrew the needle all the way, turning the large needle cover 3 to 5 full turns.
• 4. If you still cannot remove the needle, ask someone to help you. Use a new pen to administer the doseaccording to your doctor's orpharmacist's instructions.
• E. What should I do ifI cannot pull outthe black injectionbutton?This means you have used all the medicine that can be delivered accurately, even if you can still see some medicine remaining inside the cartridge.

CLEANING AND STORAGE
Cleaning your pen

• Clean the outside of the pen with a damp cloth.
• Do not put the pen in water, or wash or clean it with any liquid.

Storing your pen

• Store the pen in the refrigerator immediately after use. Read and follow the instructions in the
• Do not store the pen with the needle inserted, as this may cause air bubbles to form in the cartridge.
• Store the pen with the white cap inserted.
• Never store the pen in the freezer.
• If the medicine has been frozen, throw away the pen and use a new one.
• If the pen has been kept out of the refrigerator, do not throw it away. Store the pen in the refrigerator and contact your doctor or pharmacist.

Disposal of needles and the pen
Disposal of needles and the pen

• Before disposing of the pen, make sure you have removed the needle from the pen.
• Place used needles in a special closable container for sharps or a hard plastic container with a secure lid. Do not throw needles directly into household waste containers.
• Do not recycle the container once it is full of needles.
• Ask healthcare professionals about available options for proper disposal of this container.
• The instructions regarding needle handling should not replace local institutional or healthcare personnel regulations.
• Dispose of the device 28 days after first use.

Other important notes

• The pen contains 28 days of medicine.
• Do not transfer the medicine into a syringe.
• Write the date of the first injection on a calendar.

product.

• Check the pen label to make sure you have the correct medicine and that it is not expired.
• Contact your doctor or pharmacist if you notice any of the following: o The pen appears damaged o The solution does NOT appear clear, colorless, and free of particles.
• Use a new needle for each injection.
• During the injection, you may hear one or more clicks - this is part of the normal operation of the device.
• The pen is not recommended for use by people who are blind or have poor vision without the assistance of someone trained in the proper use of the device.
• Keep the pen out of the sight and reach of children.

Manufactured by
Novocol Pharmaceutical of Canada, Inc. 25 Wolseley Court, Cambridge, Ontario N1R-6X3, Canada
Viatris Santé, 1 rue de Turin, 69007 Lyon, France
This user manual was last revised on 11/2022