MOVYMIA 20 MICROGRAMS/80 MICROLITERS Инъекционный раствор

Содержание инструкции

1. Movymia 20 micrograms/80 microliters injectable solution
   1. What is Movymia and what is it used for
   2. What you need to know before you use Movymia
   3. How to use Movymia
   4. Possible side effects
   5. How to store Movymia
   6. Contents of the pack and other information
   7. Insert the pen needle
   8. Dose setting and injection
   9. Removing the pen needle
   10. Replace the pen cap

Movymia 20 micrograms/80 microliters injectable solution

teriparatide

Read this leaflet carefully before you start 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 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 Movymia is and what it is used for
• 2. What you need to know before you use Movymia
• 3. How to use Movymia
• 4. Possible side effects
• 5. How to store Movymia
• 6. Contents of the pack and other information

1. What is Movymia and what is it used for

Movymia contains the active substance teriparatide which is used to make bones stronger and reduce the
risk of fractures by stimulating bone rebuilding.
Movymia 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 drugs called corticosteroids.

2. What you need to know before you use Movymia

Do not use Movymia

• 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 in your blood (pre-existing hypercalcemia).
• If you have severe kidney problems.
• If you have had cancer of the bones or if other cancers 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 may mean you have Paget's disease of the bone (a condition with abnormal bone changes). If you are not sure, ask your doctor.
• If you have been treated with radiation therapy that has involved the bones.
• If you are pregnant or breastfeeding.

Warnings and precautions
Movymia can increase calcium in the blood or urine.
Talk to your doctor before or during the use of Movymia:

• If you have persistent nausea, vomiting, constipation, low energy or muscle weakness. These may be signs that there is too much calcium in your blood.
• If you suffer from or have suffered from kidney stones.
• If you suffer from kidney problems (moderate renal impairment).

Some patients experience dizziness or an increased heart rate after taking the
first doses of Movymia. During the administration of the first doses, if you feel dizzy, inject
Movymia in a place where you can sit or lie down.
The recommended treatment period of 24 months should not be exceeded.
Before inserting a cartridge into the Movymia Pen, note the batch number and the date of the first
injection on the outer container of the cartridge and provide this information in case of reporting
of undesirable effects.
Movymia should not be used in adults who are still growing.

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

Other medicines and Movymia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This is important because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart
disease) can interact with teriparatide.

Pregnancy and breastfeeding
Do not take Movymia 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 Movymia. In case of
pregnancy while using Movymia, the latter should be discontinued. Ask your doctor or
pharmacist for advice before taking any medicine.

Driving and using machines
Some patients may experience dizziness after injecting Movymia. If you feel dizzy do
not drive and do not use machines until you feel better.

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

3. How to use Movymia

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 20 micrograms (corresponding to 80 microliters) administered once a
day by 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. Movymia
can be injected at mealtimes. Inject Movymia every day for the entire period of time
that your doctor has prescribed. The total duration of treatment with Movymia should not exceed
24 months. You should not receive more than one treatment lasting 24 months for the rest of your life.
Your doctor may advise you to take Movymia with calcium and vitamin D. Your doctor will tell you how
much calcium and vitamin D you need to take each day.
Movymia can be administered with or without food.
The Movymia cartridges are designed for exclusive use with the reusable Movymia Pen multi-dose delivery
system and compatible needles. The pen and injection needles are not
supplied with Movymia. However, at the beginning of treatment you must use the cartridge and pen pack,
containing an inner box with a Movymia cartridge and an inner box containing the
Movymia Pen.
The pen can be used with injection needles developed according to the ISO standard for a
pen needle gauge between 29 G and 31 G (diameter 0.25 – 0.33 mm) and a length between
5 mm and 12.7 mm only for subcutaneous injection.
Before first use, insert the cartridge into the pen. For the correct use of this
medicine, it is very important to carefully follow the detailed instructions for use of the pen
supplied with the pen.
Always use a new needle for each injection to prevent contamination and dispose of the needle safely after use.
Never store the pen with the needle inserted.
Never share your pen with others.
Do not use Movymia Pen to inject other medicines (e.g. insulin).
The pen is customized for exclusive use with Movymia.
Do not reload the cartridge.
Do not transfer the medicine into a syringe.
You must inject Movymia shortly after taking the pen with the inserted cartridge from the
refrigerator. After use, immediately return the pen with the inserted cartridge to the refrigerator. Do not
remove the cartridge from the pen after use. Store it in the cartridge holder for the entire
treatment period of 28 days.

Preparing to use the pen

• To ensure correct administration of Movymia, always read the instructions for use of the Movymia Pen, included in the pen pack.
• Wash your hands before handling the cartridge or the pen.
• Check the expiration date on the cartridge label before inserting the cartridge into the pen. Make sure there are at least 28 days remaining before the expiration date. Insert the cartridge into the pen before first use as indicated in the pen instructions. Note the lot number of each cartridge and the date of the first injection on a calendar. You should also note the date of the first injection on the outer pack of Movymia (see the appropriate space on the box: {First use:}).
• After inserting a new cartridge and before the first injection from this cartridge, prime the pen according to the instructions provided. Do not re-prime the pen after the first dose.

Injecting Movymia

• Before injecting Movymia, clean the skin where you intend to inject (thigh or abdomen) as instructed by your doctor.
• Gently pinch a portion of clean skin and insert the needle perpendicularly into the skin. Press the button and hold it down until the dose indicator returns to the starting position.
• After the injection, leave the needle in the skin for six seconds to ensure you deliver the entire dose.
• As soon as the injection is finished, insert the protective cap onto the pen needle and screw it counterclockwise to remove the pen needle. This will keep the remaining medicine sterile and prevent it from leaking from the pen. It will also prevent air from entering the cartridge and the needle from becoming clogged.
• Replace the cap on the pen. Leave the cartridge in the pen.

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

If you forget to use Movymia
If you forget an injection or cannot make it at the time you usually do, inject it during the
day as soon as possible. Do not use a double dose to make up for a missed dose.
Do not have more than one injection in the same day.

If you stop using Movymia
If you are thinking of stopping treatment with Movymia, we invite you to discuss this with your doctor.
Your doctor will advise you and decide how long you should be treated with Movymia.
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 (very common frequency, which may affect more than 1 in 10 people). Other common side effects (may affect up to 1 in 10 people) include nausea, headache and dizziness. 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 occurred after the use of teriparatide.
If you experience discomfort around the injection site, as well as redness of the skin, pain, swelling, itching, bruising or minor bleeding (which may occur commonly), this should resolve within a few days or weeks. Otherwise, inform your doctor.
Rarely (may affect up to 1 in 1,000), some patients have suffered allergic reactions including shortness of breath, facial swelling, rash and chest pain. These reactions usually occur shortly after the injection. In rare cases, serious 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
• neuropathic pain in the legs
• feeling of fainting
• feeling of dizziness
• 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)
• vomiting
• the presence of a hernia of the channel leading food into the stomach (hiatal hernia)
• decreased hemoglobin or red blood cell count (anemia)

Uncommon(may affect up to 1 in 100 people)

• increased heart rate
• abnormal heart sounds
• labored breathing
• hemorrhoids
• 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 led to hospitalization.
• increased calcium levels in the blood
• increased uric acid levels in the blood
• increase in 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, talk to your doctor or pharmacist. This includes any possible 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 Movymia

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 cartridge after
SCAD/EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (from 2°C to 8°C). Do not freeze.
Keep the cartridge in the outer packaging to protect it from light.
You can use Movymia for up to 28 days after the first injection, during this period the cartridge/pen
with the cartridge inserted is stored in a refrigerator (2°C–8°C).
Avoid placing the pens near the ice compartment in the refrigerator to prevent
freezing. Do not use Movymia if it is or has been frozen.
After 28 days from first use, each cartridge must be disposed of appropriately, even
if it is not completely empty.
Movymia contains a colorless and clear solution. Do not use Movymia if you notice the presence of
solid particles or if the solution appears cloudy or colored.
Do not dispose of any medicine in wastewater 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 Movymia contains

• The active substance is teriparatide. Each dose of 80 microliters contains 20 micrograms of teriparatide. One cartridge of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
• The other ingredients are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections (see section 2 “Movymia contains sodium”).

Description of Movymia and contents of the pack
Movymia is a colorless and clear injectable solution (injectable). Movymia is supplied in a
cartridge. Each cartridge contains 2.4 mL of solution, sufficient for 28 doses.
Contents of the pack:
1 cartridge or 3 cartridges packaged in a sealed plastic tray with a
covering foil and contained in a carton.
Pack of Movymia containing cartridge and pen: 1 Movymia cartridge packaged in a
sealed plastic tray with a covering foil and packaged in an inner carton and
1 Movymia Pen packaged in a separate inner carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
EG (Eurogenerics) NV
Tél/Tel: +32 4797878

Lietuva
UAB „STADA Baltics“
Tel: +370 52603926

България
STADA Bulgaria EOOD
Teл.: +359 29624626

Luxembourg/Luxemburg
EG (Eurogenerics) NV
Tél/Tel: +32 4797878

Česká republika
STADA PHARMA CZ s.r.o.
Tel: +420 257888111

Magyarország
STADA Hungary Kft
Tel.: +36 18009745

Danmark
STADA Nordic ApS
Tlf: +45 44859999

Malta
Pharma.MT Ltd
Tel: +356 21337008

Deutschland
STADAPHARM GmbH
Tel: +49 61016030

Nederland
Centrafarm B.V.
Tel.: +31 765081000

Eesti
UAB „STADA Baltics“
Tel: +370 52603926

Norge
STADA Nordic ApS
Tlf: +45 44859999

Ελλάδα
FΑRAN S.A.
Τηλ: +30 2106254175

Österreich
STADA Arzneimittel GmbH
Tel: +43 136785850

España
Laboratorio STADA, S.L.
Tel: +34 934738889

Polska
STADA Poland Sp. z.o o.
Tel: +48 227377920

France
EG LABO - Laboratoires EuroGenerics
Tél: +33 146948686

Portugal
Stada, Lda.
Tel: +351 211209870

Hrvatska
STADA d.o.o.
Tel: +385 13764111

România
STADA M&D SRL
Tel: +40 213160640

Ireland
Clonmel Healthcare Ltd.
Tel: +353 526177777

Slovenija
Stada d.o.o.
Tel: +386 15896710

Ísland
STADA Arzneimittel AG
Sími: +49 61016030

Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621933

Italia
EG SpA
Tel: +39 028310371

Suomi/Finland
STADA Nordic ApS, Suomen sivuliike
Puh/Tel: +358 207416888

Κύπρος
STADA Arzneimittel AG
Τηλ: +30 2106664667

Sverige
STADA Nordic ApS
Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +370 52603926

United Kingdom (Northern Ireland)
STADA Arzneimittel AG
Tel: +49 61016030

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/

Instructions for use
Movymia Pen
Reusable pen injector to be used with Movymia cartridges for subcutaneous injections
When using the Movymia Pen system, always follow the instructions provided below and on the back
of the page.
Parts of the Movymia Pen system

Preparing the pen – First use/cartridge change
Write the date of the first injection on each new cartridge. This will help you remember
when the 28 daily doses of the cartridge were used (see section 2 “Warnings and
Follow the instructions every time you insert a new Movymia cartridge into the Movymia Pen system.
Do not repeat this operation before each daily injection, otherwise the dose
of Movymia will not be sufficient for the 28 days of therapy.
A: Remove the cap from the pen.

B: Remove the cartridge compartment by rotating it (bayonet fitting system).

C: When changing the cartridge, remove the empty cartridge. Insert a new Movymia cartridge into the
cartridge compartment, first inserting the metal cap of the cartridge.

D: Carefully reposition the threaded rod by pressing with a finger, in a straight line and pushing it all the
way down. This operation will not be necessary if the rod is already in the starting position, as in the
case of first use. It is not possible to push the threaded rod completely inside
the pen housing.

E: Reconnect the cartridge compartment to the housing by rotating it 90 degrees, until it clicks into place.

F: Insert a new pen needle as follows:

• Remove the protective film.

• Screw the pen needle clockwise onto the cartridge compartment. Make sure the pen needle is correctly inserted and firmly attached to the cartridge compartment.

• Remove and discard the outer cap of the needle.

• Remove and discard the inner cap of the needle.

A few drops may fall during needle insertion, this is normal.
G: Priming
After inserting a new cartridge and before the first injection of each cartridge, the pen
must be primed and tested.

• Rotate the dosage selection dial clockwise until the drop symbol appears on the dial (display). Make sure the two strips of the indicator are aligned. During dose selection, the pen will emit an audible click and offer noticeable resistance.

• Hold the pen with the needle pointing upwards.
• Press the button all the way down. Hold it down until the dosage indication returns to the initial position. The tip of the needle should expel a few drops of medicine.

If no drops come out, repeat step G until drops are noticed. Do not repeat
step G more than 4 times, but follow the instructions provided in the troubleshooting section on the back of the page.

Administration using the Movymia Pen System
Wash your hands thoroughly with soap to minimize the risk of infection.
Make sure you have ready:

• the Movymia Pen system with the cartridge inserted
• a compatible pen needle
• a sharps container for the disposal of sharps and used needles.

Do not usethe pen if the cartridge is cloudy, has a changed color or if it contains particles.

1. Insert the pen needle

Use a new needle for each injection. Do not use the pen needle if the packaging is damaged or has not been opened by you.

Note:it is not necessary to change the needle when using the pen immediately after its preparation. In this case, proceed with step “2. Dose setting and injection”.

• Remove the protective film.

• Screw the pen needle clockwise onto the cartridge compartment. Ensure that the pen needle is correctly inserted and is securely fastened to the cartridge compartment.

• Remove the outer cap of the needle and keep it.

• Remove and discard the inner cap of the needle.

During the insertion of the needle, a few drops may fall, this is normal.

2. Dose setting and injection

Warning:Ensure the correct medicine is used. Check the cartridge label before inserting it into the cartridge compartment.

• To set the established daily dose of 80 microliters, rotate the dosage selection knob clockwise until it locks and can no longer be rotated. Ensure that the dial (display) shows the arrow mark and that it is aligned with the indicator strip. During dose selection, the pen will emit an audible click and offer noticeable resistance. Do not force the dosage selection knob further.

Warning:If the cartridge contains less than 80 microliters, the dosage selection knob cannot be rotated clockwise to the arrow mark. In this case, remove the needle from the pen, change the cartridge, and proceed with loading according to the previously reported pen preparation steps.

• Choose an appropriate injection site and prepare the skin according to your doctor's recommendations. Gently pinch a portion of skin between your thumb and index finger. Insert the needle perpendicularly and gently into the skin, as shown in the figure.

Warning:Avoid bending or breaking the needle. Do not tilt the pen after inserting the needle into the skin. Tilting the pen may cause the needle to bend or break. Broken needles can remain inside the skin. Consult a doctor immediately if a broken needle remains in the skin.

• Press the button until the dose indication returns to the starting position. Keep the needle in the skin for another 6 seconds.

• Slowly remove the pen. Verify that the dial (display) is in the initial position to ensure that the entire dose has been injected.

3. Removing the pen needle

• Carefully place the outer cap of the needle onto the pen needle.

• Unscrew the needle cap in a counterclockwise direction to remove the pen cap. Dispose of it correctly, for example in a sharps container.

4. Replace the pen cap

• Do not remove the cartridge from the Movymia Pen system until it is empty.
• Replace the pen cap after each use.

• Immediately after use, replace the Movymia Pen system, with the cartridge inserted, in the refrigerator, between 2 and 8 °C.

Note for healthcare professionals
Instructions regarding the handling and disposal of needles may be replaced by local, health or institutional policies.

Additional information
The fixed-dose reusable pen is designed for easy administration of Movymia to treat osteoporosis. Each Movymia cartridge contains 28 fixed doses of 80 microliters of Movymia.
The Movymia Pen system should only be used as prescribed by your doctor, these instructions for use and the Movymia package leaflet.
For self-injection, the Movymia Pen system can be used by patients over 18 years of age, healthcare professionals and third parties, such as adult relatives.
The Movymia Pen system should not be used by patients who are blind or have impaired vision, without the help of a physically able and trained person.
Consult your doctor if you have hearing problems or difficulty with manipulation.
The pen needles must be used only onceand the Movymia cartridge must be used by only one person.

Storage and care of the Movymia Pen system

• Handle the pen with care. Do not drop the pen and avoid impacts against hard surfaces. Keep away from water, dust and humidity.
• To clean the Movymia Pen system, a damp cloth is sufficient. Do not use alcohol, other solvents or cleaning agents. Do not immerse the Movymia Pen system in water, as this could damage the pen.
• Do not use the Movymia Pen system if it is damaged or if you doubt its correct operation.
• Transport and store the Movymia Pen system with the cartridge inserted at temperatures
• Store the Movymia Pen system, cartridges and pen needles out of the reach of children.
• Do not store the Movymia Pen system with the needle inserted as this may cause air bubbles to form in the cartridge.

Disposal of the Movymia Pen system and used accessories
The Movymia Pen system has a lifespan of 2 years. Before disposing of the Movymia Pen system, always remove the needle and cartridge. Used needles and cartridges must be disposed of separately and safely. The Movymia Pen system can be disposed of according to the instructions of local authorities.

Warnings
Follow the instructions presented in these instructions for use. If the instructions are not followed, there is a risk of incorrect therapy, inaccurate dosage, transmission of disease or infection. In case of any health problems, seek immediate medical assistance.

Troubleshooting
If you have any doubts about using the Movymia Pen system, follow the instructions provided in the table:

These instructions for use were last revised on: