LIVOGIVA 20 MCG/80 MCL Инъекционный раствор

Содержание инструкции

1. Livogiva 20 micrograms/80 microliters injectable solution in pre-filled pen
   1. What is Livogiva and what is it used for
   2. What you need to know before you take Livogiva
   3. How to take Livogiva
   4. Possible side effects
   5. How to store Livogiva
   6. Contents of the pack and other information

Livogiva 20 micrograms/80 microliters injectable solution in pre-filled pen

teriparatide

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 their symptoms are the same as yours, as it may 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 Livogiva is and what it is used for
• 2. What you need to know before you use Livogiva
• 3. How to use Livogiva
• 4. Possible side effects
• 5. How to store Livogiva
• 6. Contents of the pack and other information

1. What is Livogiva and what is it used for

Livogiva contains the active substance teriparatide which is used to make bones stronger and reduce the
risk of fractures by stimulating bone regeneration.
Livogiva 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 in
treatment with corticosteroids.

2. What you need to know before you take Livogiva

Do not take Livogiva

• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6)
• if you have high levels of calcium (pre-existing hypercalcemia)
• if you have severe kidney problems
• if you have ever been diagnosed with bone cancer or other cancers that have spread to the bones (metastases)
• if you have other bone diseases; if you have a bone disease, tell your doctor
• if you have high levels of alkaline phosphatase in the blood of unknown origin, this may mean you 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 radiotherapy involving the bones
• if you are pregnant or breastfeeding.

Warnings and precautions
Livogiva can cause an increase in the amount of calcium in the blood or urine.
Talk to your doctor or pharmacist before or during taking Livogiva:

• if you have persistent nausea, vomiting, constipation, loss of energy or muscle weakness. These may be signs of too much calcium in the blood;
• if you suffer from kidney stones or if you have had kidney stones in the past;
• if you suffer from kidney problems (moderate renal impairment).

Some patients experience dizziness or an increased heart rate after taking the
first doses. During the administration of the first doses, if you feel dizzy, inject Livogiva in a
place where you can sit or lie down.
The recommended treatment period of 24 months should not be exceeded.
Livogiva should not be used in young adults.

Children and adolescents
Livogiva should not be used in children and adolescents (under 18 years of age).

Other medicines and Livogiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, because occasional interactions can occur (e.g.
digoxin/digitalis, a medicine used to treat heart disease).

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

Driving and using machines
Some patients may experience dizziness after injection of Livogiva. If you feel dizzy do not
drive vehicles and do not use machines until you feel better.

Livogiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.

3. How to take Livogiva

Take 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 by injection under
the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to use the
medicine, inject it every day at the same time.
Inject Livogiva every day for the entire period of time that your doctor has prescribed. The total duration
of treatment with Livogiva should not exceed 24 months. You should not receive more than one
treatment lasting 24 months during your lifetime.
Your doctor may advise you to use Livogiva with calcium and vitamin D and will tell you how much calcium and
vitamin D to take each day.
Read the user manual, which is included in the package, for instructions on how to use
Livogiva.
Injection needles are not included in the pen package. You can use pen injection needles with gauge 29-31 (diameter 0.25-0.33 mm).
You should proceed with the injection of Livogiva shortly after taking the pen from 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. Do not
ever store the pen with the needle inserted. Never share your Livogiva pen with other people.
Livogiva can be taken independently of meals.

If you take more Livogiva than you should
If you have taken more Livogiva than you should, by mistake, contact your doctor or pharmacist.
The expected effects of an overdose include nausea, vomiting, dizziness and headache.

If you forget or are unable to take Livogiva at the time you usually do,proceed
with the injection during the day as soon as possible. Do not use a double dose to make up for the
missed dose. Do not have more than one injection on the same day. Do not try to
make up for a missed dose.

If you stop taking Livogiva
If you are thinking of stopping treatment with Livogiva, discuss it with your doctor first. Your doctor
will advise you and decide how long you should continue treatment with Livogiva.
If you have any doubts about 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 your doctor before continuing treatment. Cases of
fainting have been reported with the use of teriparatide.
If you experience discomfort, such as redness of the skin, pain, swelling, itching,
small localized bruise or minimal 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 pain in the legs
• 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)
• presence of a hernia of the channel leading food to the stomach
• decreased hemoglobin or number of red blood cells (anemia)

Not common: may affect up to 1 in 100 people

• 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 had 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 people

• reduced kidney function, including kidney failure
• appearance of swelling, especially in the hands, feet and legs.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system as detailed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Livogiva

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 pack and on the pen after
“Exp.”. The expiry date refers to the last day of that month.
Livogiva must always be stored in a refrigerator (temperature from 2°C to 8°C). You can use Livogiva
for up to 28 days after the first injection; during this period the pen is stored in a refrigerator
(temperature from 2°C to 8°C).
Avoid storing the pens near the ice compartment in the refrigerator to prevent freezing. Do not use Livogiva if it is or has been frozen.
After 28 days, each pen must be disposed of appropriately, even if it is not
completely empty.
Livogiva contains a colourless and clear solution. Do not use Livogiva if you notice the presence of solid
particles or if the solution appears cloudy or discoloured.
Do not dispose of any medicine in the drains or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Livogiva contains

• The active substance is teriparatide. Each millilitre of injectable solution contains 250

micrograms of teriparatide. Each pre-filled pen containing 2.7 mL contains 675 micrograms of
teriparatide (corresponding to 250 micrograms per mL).

• The excipients are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol and water for injections. See section 2.

Description of Livogiva and contents of the pack
Livogiva is a colourless and clear solution. Livogiva is supplied in a cartridge contained in a
single-use pre-filled pen. Each pen contains 2.7 mL of solution sufficient for 28 doses.
Livogiva is available in packs containing one or three pre-filled pens.
Not all pack sizes may be available.

Marketing Authorisation Holder
Theramex Ireland Limited
3rd Floor Kilmore House, Park Lane, Spencer Dock
DO1 YE64 Dublin 1
Ireland

Manufacturer
Eurofins PROXY Laboratories (PRX)
Archimedesweg 25 2333 CM Leiden
Netherlands

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

USER MANUAL
Livogiva 20 micrograms/80 microlitres injectable solution in pre-filled pen
IMPORTANT INFORMATION
and this user manual contained in the Livogiva box. Follow the instructions carefully when using the Livogiva pen.

Livogiva Pen and Parts
Pen needles with gauge 29-31 (diameter 0.25-0.33 mm) can be used.

Needles not included.

Instructions for use
Preparing for the injection
Step 1
Prepare the site
and remove the
cap
A)Wash your hands before each
injection.

B)Prepare the injection site (thigh
or abdomen) as recommended
by your doctor or pharmacist.

C)Remove the white cap
by pulling it off the device
(Figure B).

Step 2
Check the
pen, the pen
label and the
medicine
A)Check the pen.

DO NOTuse the Livogiva pen if it is
damaged.

B)Check the pen label.

DO NOTuse the pen if it contains the
wrong medicine or if the
medicine has expired (Figure C).

C)Check the medicine cartridge. The liquid
medicine must be clear and transparent.

DO NOTuse the medicine if it is cloudy,
coloured or has particles suspended in it.
(Figure C).

Step 3
Attach a
new needle
A)Peel off the paper tab
(Figure D).

B)Push the needle

perpendicularlyinto the
medicine cartridge (Figure
E).

Screw the needle on clockwise until it is firmly attached (Figure F).

Do notovertighten the needle.

Step 4
Remove the
outer needle
protection
Remove the large outer needle protection (Figure G) and keep it for
later use(see Step 9).

Step 5
Set the
dose
Pushthe black injection button
outwards until it stops.(Figure H).

Checkto make sure the red line is visible.
Also, the instruction window
will show an arrow pointing towards the end of the pen
containing the needle (Figure I).

Troubleshooting dose setting
If the pen does not set completely or if you cannot pull the black injection button back, see Troubleshooting E.

Administering the injection
Step 6
Remove the
inner needle
protection
Pulloff the small inner needle protection and discard it. (Figure J). The needle
is visible.

Step 7
Inject the
dose
Gently pinch a fold of skin on the
thigh or abdomen and insert the needle
perpendicularly into the pinched skin
(Figure K).

B)Press the black injection button until

it stops and hold it in place
(Figure L).

C)Hold it in place and count s-l-o-w-l-y

to 5to make sure the entire dose is delivered (Figure M).
You may not see the black injection button move. To confirm
that the dose has been delivered, see Step 8 “Confirming the dose”.

D)Remove the needle from the skin (Figure N).

When the needle is removed from the skin, release your
thumb from the black injection button.

After the injection
Step 8
Confirming the
dose
Checkto make sure the black
injection button is fully
inserted. The instruction window
will show an arrow pointing TOWARDS
the black button.
If you do not see the yellow bar, you have
correctly completed the injection steps. (Figure O)

Important
DO NOTsee any part of the yellow bar.
If you see it and have already injected the
medicine DO NOTtake a second
injection on the same day.
Instead, YOU MUST reset the pen.
See Troubleshooting A

Step 9
Removing and
disposing of
the needle
A)Place the large outer needle protection over the needle
and press it against it
(Figure P and Q). Do not try to
re-attach the needle protection
with your hands.

B)Unscrew the covered needle completely
by turning the large outer needle protection 3-5 times counter-clockwise. (Figure R)
Pull the needle off firmly (Figure
S).

C)Dispose of the needle in a sharps container according to
local regulations (Figure T).

Do notreuse the needle.

Disposing of needles
For more information on how to properly dispose of the needle, refer to the paragraph

Information for disposal

Step 10
Recap and
store the
pen
A)Put the white cap back on
(Figure U).

B)After use, always store the
pen in the refrigerator with the white cap on. (Figure V)

Do notstore the pen with a
needle attached.

Troubleshooting
ProblemSolution
AThe white bar is still visible after
pushing the black injection button.
How do I reset Livogiva?
To reset the Livogiva pen, follow these
steps:

• 1)If you have already taken the injection DO NOTtake a second injection on the same day. Use a new injection needle the next day.
• 2)Remove the needle
• 3)Insert a new needle, remove the large needle protection and keep it.
• 4)Remove the inner needle protection and discard it.
• 5)Point the needle downwards into an empty container. Push the black injection button until it stops. Hold it in place and count s-l-o-w-l-y to 5. You may see a flow or leakage of liquid. When you are finished, the black injection button must be fully inserted.
• 6)If you still see the yellow bar, do not use this pen, contact your doctor or pharmacist.
• 7)Put the large needle protection over the needle. Unscrew the needle completely by turning the large needle protection 5-3 times. Detach the needle protection and dispose of it as instructed by your doctor or pharmacist. Replace the cap and store Livogiva in the refrigerator.

You can avoid this problem by always using a NEW needle for each injection and pushing the black
injection button all the way in and counting s-l-o-w-
l-y to 5.
BHow can I tell if Livogiva
is working?
Livogiva is designed to inject the full dose each
time it is used by following the instructions contained
in the Instructions for usesection.
The black injection button must be
fully inserted to demonstrate that the entire dose of medicine has been injected. Use a new needle
each time you inject to ensure that
Livogiva is working correctly.

CI see an air bubble inside
Livogiva.
A small air bubble will not affect the dose and will not
be harmful to you. You can continue to use the normal dose.

DI cannot remove the needle. 1)Place the large needle protection over the needle.

• 2)Use the large needle protection to unscrew the needle.
• 3)Unscrew the needle completely by turning the large needle protection 3-5 times counter-clockwise.
• 4)If you still cannot remove the needle, ask someone for help. See Step 9 “Removing and disposing of the needle”. EWhat should I do if I cannot pull the black injection button back? Use a new Livogiva pen to get the doseas instructed by your doctor or nurse.When it becomes difficult to pull the black injection button back, it means there is not enough medicine left in the Livogiva pen for another dose. You may still notice some medicine remaining in the cartridge.

Cleaning and storage
How to clean the Livogiva pen

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

How to store the Livogiva pen

• DO NOTstore Livogiva with a needle attached. This could compromise the sterility of the medicine for subsequent injections.
• Store Livogiva with the white cap on.
• If Livogiva has been left out of the refrigerator, do not throw the pen away. Put the pen back in the refrigerator and contact your doctor or pharmacist.

Information for disposal
Disposing of pen needles and the Livogiva pen

• Before throwing away the Livogiva pen, make sure to remove the needle from the pen.
• Place used needles in a sharps container or a hard plastic container with a tight-fitting lid. Do not throw needles directly into household waste.
• Do not recycle the full sharps container.

Other important notes

• DO NOTtransfer the medicine into a syringe.
• During the injection, you may hear one or more clicks - this is part of the normal operation of the pen.
• Livogiva is not recommended for use by blind or visually impaired individuals without assistance from a person trained in the correct use of the pen.

This user manual was updated on: