IZAMBY 60 mg /Ml Инъекционный Раствор В Преднаполненном Шприце

Содержание инструкции

1. Izamby 60 mg injectable solution in pre-filled syringe
   1. What Izamby is and what it is used for
   2. What you need to know before you use Izamby
   3. How to use Izamby
   4. Possible side effects
   5. How to store Izamby
   6. Package Contents and Other Information
   7. Preparation for Izamby Injection
   8. Preparation
   9. Izamby Injection
   10. Disposal of Izamby

Izamby 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 medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you 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 Izamby.

Contents of this leaflet

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

1. What Izamby is and what it is used for

What Izamby is and how it works
Izamby contains denosumab, a protein (monoclonal antibody) that interferes with the action of
another protein, for the treatment of bone loss and osteoporosis. Treatment with
denosumab makes bones stronger and less prone to fractures.
Bone is a living tissue that is constantly being renewed. Estrogens help to keep bones
healthy. After menopause, the reduction 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, femur and wrists.
Surgical interventions or medications that stop the production of estrogen or testosterone,
used to treat patients with breast or prostate cancer, can also cause
bone loss. The bones thus become more fragile and fracture more easily.

What type of treatment Izamby is used for
Izamby 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 femoral fractures.
• bone loss in men resulting from a reduction in hormone levels (testosterone) 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 Izamby

Do not use Izamby

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

Warnings and precautions
Talk to your doctor or pharmacist before using Izamby.
During treatment with Izamby 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 Izamby you must also take calcium and vitamin D supplements. Your doctor
will discuss this with you.
During treatment with Izamby 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 of the hands, the 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 may 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
An undesirable effect called osteonecrosis of the jaw (severe degeneration of the jaw bone
tissue) 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 increases in patients
treated for a long period (may occur in up to 1 in 200 if treated for 10 years).
Osteonecrosis of the jaw can also occur after stopping treatment. It is important
to try to prevent the development of osteonecrosis of the jaw as it is a painful condition
that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the
jaw, 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 disorders, 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 may increase the risk of dental disorders);
• 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.

The doctor may ask you to have a dental check-up (from the dentist) before starting
treatment with Izamby.
During treatment it is necessary to maintain good oral hygiene and undergo periodic dental
check-ups. If you wear dentures, you need to make sure 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 the dentist that you are in
treatment with Izamby.
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 presence of
discharge, as these may be signs of an undesirable effect called osteonecrosis of the
jaw (ONJ).
Atypical femur fractures
Some people have developed atypical femur fractures during treatment with denosumab.
Contact your doctor if you experience new or unusual pain in the hip, groin or thigh.

Children and adolescents
Izamby must not be used in children and adolescents under the age of 18 years.

Other medicines and Izamby
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 Izamby together with other medicines that contain denosumab.

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

Driving and using machines
Izamby does not alter or alters to a negligible extent the ability to drive vehicles or use machines.

Izamby contains sorbitol
This medicine contains 46 mg of sorbitol per mL of solution.

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

Izamby contains polysorbate
This medicine contains 0.1 mg of polysorbate 20 (E 432) per syringe equivalent to
0.1 mg/mL. Polysorbates can cause allergic reactions. Tell your doctor if you have known allergies.

3. How to use Izamby

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
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. Discuss with your doctor the date of the possible next injection.
Each pack of Izamby contains a reminder card, which can be used to keep track of
the date of the next injection.
During treatment with Izamby, 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
Izamby. Your doctor or nursing staff will show you or the person assisting you how to
use Izamby. For instructions on how to inject Izamby, see the section at the end of this
Do not shake.
Before administration, the solution must be inspected. Do not inject the solution if
it contains particles or if it appears cloudy or has changes in color.

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

If you stop using Izamby
To get the maximum benefit from treatment in reducing the risk of fractures, it is important
to take Izamby 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 commonly, patients treated with Izamby may develop skin infections
(especially cellulitis). Tell your doctor immediatelyif any of these symptoms occur
while you are taking Izamby: appearance of redness and swelling of the skin, most commonly in the
lower leg, with a feeling of warmth and pain and with possible feverish symptoms.
Rarely, patients treated with Izamby may develop pain in the mouth and/or
jaw, swelling or sores that do not heal in the mouth or jaw, presence of
discharge, numbness or feeling of heaviness in the jaw, or loosening of a tooth.
These could be signs of a serious degeneration of the jaw bone tissue
(osteonecrosis). Tell your doctor and dentist immediatelyif you experience these symptoms during
treatment with Izamby or after stopping treatment.
Rarely, patients treated with Izamby 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 muscle cramps, 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 the heart rhythm
called prolongation of the QT interval, which is detected by electrocardiogram (ECG).
Rarely, atypical femur fractures can occur in patients treated with Izamby.

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 Izamby. 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 Izamby.

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 skin level (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 listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Izamby

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 carton after
Exp/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 the injection. This will make the injection more comfortable.
Once the syringe has reached room temperature (up to 25 °C), it must be used
within 30 days.
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. Package Contents and Other Information

What Izamby contains

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

Description of the appearance of Izamby and package contents
Izamby is an injectable liquid from colorless to yellowish, in a pre-filled syringe ready for use.
Each pack contains one pre-filled syringe with needle protection.

Marketing Authorisation Holder
Mabxience Research SL
C/ Manuel Pombo Angulo 28
28050 Madrid
Spain

Manufacturer
GH GENHELIX S.A.
Parque Tecnológico de León
Edifício GENHELIX
C/Julia Morros, s/n
Armunia, 24009 León, Spain
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Mabxience Research SL
Tél/Tel: + 34 917 711 500

Lietuva
UAB EGIS Lithuania
Tel: + 370 5 231 4658

България
EGIS Bulgaria
Teл.: + 359 2 987 60 40

Luxembourg/Luxemburg
Mabxience Research SL
Tél/Tel: + 34 917 711 500

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

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

Danmark
Medical Valley Invest AB
Tlf: + 46 40 122131

Malta
Mabxience Research SL
Tel: + 34 917 711 500

Deutschland
Mabxience Research SL
Tel: + 34 917 711 500

Nederland
Medical Valley Invest AB
Tel: + 46 40 122131

Eesti
Mabxience Research SL
Tel: + 34 917 711 500

Norge
Medical Valley Invest AB
Tlf: + 46 40 122131

Ελλάδα
ELPEN Pharmaceutical Co. Inc
Τel: + 30 210 6039326-9

Österreich
Gebro Pharma GmbH
Tel: + 43 (0)5453 5300-0

España
Laboratorios Gebro Pharma S.A
Tel: + 34 93 205 86 86

Polska
Egis Polska sp. z o.o.
Tel.: + 48 22 417 92 00

France
Laboratoires Biogaran
Tél: + 33 (0) 800 970 109

Portugal
Mabxience Research SL
Tel: + 34 917 711 500

Hrvatska
Mabxience Research SL
Tel: + 34 917 711 500

România
Egis Rompharma SRL
Tel: + 40 21 412 00 17

Ireland
Mabxience Research SL
Tel: + 34 917 711 500

Slovenija
Mabxience Research SL
Tel: + 34 917 711 500

Ísland
Mabxience Research SL
Sími: + 34 917 711 500

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

Italia
Abiogen Pharma S.p.A
Tel: + 39 050 315 4101

Suomi/Finland
Medical Valley Invest AB
Puh/Tel: + 46 40 122131

Κύπρος
Mabxience Research SL
Τηλ: + 34 917 711 500

Sverige
Medical Valley Invest AB
Tel: + 46 40 122131

Latvija
Egis Latvia SIA
Tel: + 371 676 13859

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

Instructions for use
Read these instructions before starting to use the Izamby pre-filled syringes with needle protection and each time you receive a new pack. There may be new information. You should also consult your healthcare professional regarding your medical condition or your treatment.
Keep these Instructions for Use for future reference.

IMPORTANT INFORMATION
Important information to know before injecting Izamby:

• It is important that you do not attempt to inject unless you have received adequate instructions from your doctor or healthcare professional on how to inject Izamby correctly.
• Izamby is administered only as a subcutaneous injection (injection directly under the skin).
• Do notopen the outer packaging until you are ready to use this medicinal product.
• Do notremove the needle cap from the pre-filled syringe until you are ready to inject.
• Do notuse the pre-filled syringe if it has fallen onto a hard surface. Use a new pre-filled syringe and contact your doctor or healthcare professional.
• Do notattempt to activate the pre-filled syringe before injection.
• Do notattempt to remove the needle protection from the pre-filled syringe.

Contact your doctor or healthcare professional if you or the person assisting you has any questions about how to inject Izamby correctly.
Figure 1 shows the appearance of the pre-filled syringe with needle protection before (a) and after (b) use.

a) Before use	b) After use
n a Plunger Used plunger i l a IZAMBY t I Used syringe cylinder a Handle i IZAMBY Used needle z Syringe label n Syringe cylinder Spring of the used needle protection e Spring of the needle protection g Removed needle cap A Inserted needle cap

Figure 1

1. Preparation for Izamby Injection

Gathering the Materials

• On a clean and well-lit work surface, gather the materials needed for the injection: o Izamby package with prefilled syringe o Alcohol-soaked cotton balls o Cotton ball or gauze o Adhesive bandage o Sharps container for disposal of sharp materials

Let it Reach Room Temperature

• For a more comfortable injection, leave the package with the prefilled syringe inside at room temperature for approximately 30 minutes before the injection ( Figure A). o Do nottry to warm the prefilled syringe using a heat source such as hot water or a microwave oven. o Do notexpose the prefilled syringe to direct sunlight. o Do notshake the prefilled syringe. o Keep the prefilled syringe out of the sight and reach of children.

Figure A
Wash Your Hands

• Wash your hands thoroughly with soap and water ( Figure B).

Figure B
Remove the Prefilled Syringe from the Package

• Open the package.
• Grasp the prefilled syringe by the syringe body ( Figure C).
• Lift the syringe, removing it from the package.
• Place the syringe on a clean, flat work surface. For safety reasons:
• Do notgrasp the plunger.
• Do notgrasp the needle cap.

Figure C
Check the Medicine and Prefilled Syringe

• Check that the medicine name “Izamby” is printed on the label ( Figure D).
• Check the expiration date printed on the label ( Figure D).
• Check that the medicine appears as a clear solution, from colorless to slightly yellow ( Figure D).
• Check if the prefilled syringe is damaged.

Do notuse the prefilled syringe if:

• The medicine is cloudy or there are particles inside.
• Any parts appear cracked or broken.
• The needle cap is missing or is not securely attached.
• The expiration date printed on the label has passed the last day of the indicated month.

In all of the above cases, contact your doctor or healthcare provider.

Figure D

2. Preparation

Prepare the injection site

• Choose the injection site ( Figure E): You can use:
• The upper part of the thigh.
• The abdomen, except for an area of 5 centimeters around the navel.
• The upper outer part of the arm (only if someone else is giving you the injection).
• Do notinject into areas where the skin is sensitive, bruised, reddened, or hardened. Avoid injecting into areas with scars or stretch marks.

Figure E
Clean the injection site

• Clean the injection site with a cotton ball soaked in alcohol ( Figure F).
• Allow the skin to dry.
• Do nottouch the injection site before the injection.

Figure F
Remove the needle cap

• Carefully remove the needle cap outwards and away from your body ( Figure G).
• Dispose of the needle cap.
• Do nottry to reposition the cap on the needle.

Figure G

3. Izamby Injection

Insert the needle

• Lift the injection site to create a stable surface ( Figure H).
• Do nottouch the cleaned area of skin. Note:it is important to keep the skin lifted during the injection.
• Insert the needle at a 45-90 degree angle into the lifted skin ( Figure I).

Figure H

Figure I
Izamby Injection

• Push the plunger slowly and completely until all the liquid has been injected and the syringe is empty ( Figure J).

Note:the plunger must be pushed all the way down to ensure that the entire dose has been injected and
that the needle protection is activated.

Figure J
Release your thumb

• Release your thumb from the plunger to allow the needle protection to cover the needle ( Figure K).
• Then move the syringe away from the skin ( Figure L).
• Release the lifted skin.

Contact your doctor or healthcare provider immediately if:

• You have not injected the entire dose or
• The needle protection does not activate after the injection.

Figure K

Figure L

1. Disposal of Izamby

Dispose of the syringe

• Throw the used pre-filled syringe and other materials into a sharps disposal container ( Figure M). Note:medicines must be disposed of in accordance with local regulations. Ask your doctor or healthcare professional how to dispose of medicines you no longer use. This will help protect the environment.
• Do notreplace the needle cap on used pre-filled syringes.
• Do notreuse the pre-filled syringe even if not all of the medicine has been injected.
• Do notrecycle pre-filled syringes or throw them in household waste.
• Keep the syringe and sharps disposal container out of sightand reach of children.

Figure M
Examine the injection site

• If you notice blood, press a cotton ball or gauze onto the injection site.
• Do notrub the injection site. If necessary, apply a bandage.

Record the date of the next injection

• Record the date of the next injection on the reminder card included in the package ( Figure N).

Figure N