Firmagon

Helstu upplýsingar

  • Heiti vöru:
  • Firmagon
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Firmagon
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • ENDOCRINE THERAPY
  • Lækningarsvæði:
  • Prostatic Neoplasms
  • Ábendingar:
  • Firmagon is a gonadotrophin-releasing-hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
  • Vörulýsing:
  • Revision: 13

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000986
  • Leyfisdagur:
  • 16-02-2009
  • EMEA númer:
  • EMEA/H/C/000986
  • Síðasta uppfærsla:
  • 28-03-2019

Opinber matsskýrsla

European Medicines Agency

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged.

EMEA/H/C/986

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

FIRMAGON

EPAR summary for the public

This document is a summary of the European Public Assessment Report (EPAR). It explains how

the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to

reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package

Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more

information on the basis of the CHMP recommendations, read the Scientific Discussion (also part

of the EPAR).

What is Firmagon?

Firm

agon is a powder and solvent that are made up into a solution for injection. It contains the active

substance degarelix.

What is Firmagon used for?

Firm

agon is used to treat patients with advanced prostate cancer. This is cancer that affects the

prostate gland, the gland below the bladder in men that produces the liquid in the semen. ‘Advanced’

means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs.

Firmagon can be used if the cancer is ‘hormone-dependent’, which means that it responds to

treatments that reduce the levels of the hormone testosterone.

The medicine can only be obtained with a prescription.

How is Firmagon used?

Firm

agon is injected under the skin of the abdomen. Treatment starts with two 120-mg injections,

followed by single 80-mg injections every month. Firmagon must not be injected into a vein or a

muscle. Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of

testosterone and prostate-specific antigen (PSA). PSA is a protein that is produced by the prostate

gland and is often found at high levels in men with prostate cancer.

Firmagon should be used with caution in patients who have severe kidney or liver problems.

How does Firmagon work?

Testosterone can m

ake prostate cancer cells grow. The active substance in Firmagon, degarelix, is a

gonadotrophin-releasing hormone antagonist, which means that it blocks the effects of a natural

hormone called gonadotrophin-releasing hormone (GnRH). GnRH normally stimulates the pituitary

gland at the base of the brain to produce two hormones which cause the testes to produce testosterone.

By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows

down the growth of the cancer cells. When injected, Firmagon forms a gel under the skin that releases

the active substance slowly over a few weeks.

How has Firmagon been studied?

The effects of Firmagon were first tested

in experimental models before being studied in humans.

Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men

with prostate cancer at all stages of the disease. The main measure of effectiveness was the number of

patients whose testosterone levels were below those seen in men whose testes were producing no

testosterone, over the first year of treatment.

What benefit has Firmagon shown during the studies?

Firmagon was as effective as leuprorelin at reducing testosterone levels. During the first year, 97% of

the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone

levels below the required level. This was compared with 96% of patients receiving leuprorelin. Similar

results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.

What is the risk associated with Firmagon?

The m

ost common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and

problems at the injection site such as pain and redness. For the full list of all side effects reported with

Firmagon, see the Package Leaflet.

Firmagon should not be used in people who may be hypersensitive (allergic) to degarelix or any of the

other ingredients.

Why has Firmagon been approved?

The Committee for Medicinal Products f

or Human Use (CHMP) noted that Firmagon was as effective

as leuprorelin in the main study. However, because the main study looked at the medicine’s effects on

testosterone levels rather than the cancer or the patient’s outcome directly, and because leuprorelin is

only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon

to advanced prostate cancer.

The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in

testosterone levels seen with ‘GnRH agonists’ (other medicines for prostate cancer that stimulate the

production of GnRH). This means that patients do not need to take other medicines to block

testosterone at the start of treatment.

Therefore, the CHMP decided that Firmagon’s benefits are greater than its risks for the treatment of

adult male patients with advanced hormone-dependent prostate cancer. The Committee recommended

that Firmagon be given marketing authorisation

Which measures are being taken to ensure the safe use of Firmagon?

The com

pany that makes Firmagon will make sure that educational materials are provided to all

doctors in all Member States who will prescribe the medicine. The materials will include information

on Firmagon’s safety and remind doctors how to administer the medicine.

Other information about Firmagon:

The European Commissio

n granted a marketing authorisation valid throughout the European Union

for Firmagon to Ferring Pharmaceuticals A/S on 17 February 2009.

The full EPAR for Firmagon can be found here

This summary was last updated in 01-2009.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

FIRMAGON 80 mg powder and solvent for solution for injection

Degarelix

Read all of this leaflet carefully before you start using this medicine because it contains important

information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed in

this leaflet. See section 4.

What is in this leaflet:

What FIRMAGON is and what it is used for

What you need to know before you use FIRMAGON

How to use FIRMAGON

Possible side effects

How to store FIRMAGON

Contents of the pack and other information

1.

What FIRMAGON is and what it is used for

FIRMAGON contains degarelix.

Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients.

Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its

effects. By doing so, degarelix immediately reduces the level of the male hormone testosterone that

stimulates the prostate cancer.

2.

What you need to know before you use FIRMAGON

Do not use FIRMAGON

If you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Please tell your doctor if you have any of the following:

Any cardiovascular conditions or heart rhythm problems (arrythmia), or are being treated with medicines

for this condition. The risk of heart rhythm problems may be increased when using FIRMAGON.

Diabetes mellitus. Worsening or onset of diabetes may occur. If you have diabetes, you may have to

measure blood glucose more frequently.

Liver disease. Liver function may need to be monitored.

Kidney disease. Use of FIRMAGON has not been investigated in patients with severe kidney disease.

Osteoporosis or any condition that affects the strenght of your bones. Reduced level of testosterone may

cause a reduction in bone calcium (thinning of bones).

Severe hypersensitivity. Use of FIRMAGON has not been investigated in patients with severe

hypersensitivity reactions.

Children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and FIRMAGON

FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine,

procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g.

methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic),

antipsychotics).

Tell your doctor if you are taking, have recently taken or might take any other medicines, including

medicines obtained without a prescription.

Driving and using machines

Tiredness and dizziness are common side effects that may impair your ability to drive and use machines.

These side effects may be due to the treatment or effects resulting from the underlying disease.

3.

How to use FIRMAGON

This medicine is usually injected by a nurse or a doctor.

The recommended starting dose is two consecutive injections of 120 mg. After that, you will receive a

monthly 80 mg injection. The injected liquid forms a gel from which degarelix is released over a period of

one month.

FIRMAGON must be injected under the skin (subcutaneously) ONLY. FIRMAGON must NOT be given

into a blood vessel (intravenously). Precautions must be taken to avoid accidental injection into a vein. The

site of injection is likely to vary within the abdominal region.

If you forget to use FIRMAGON

If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

A very serious allergic reaction to this medicine is rare. Seek medical advice straight away if you develop a

severe rash, itching or shortness of breath or difficulty breathing. These could be symptoms of a severe

allergic reaction.

Very common (may affect more than 1 in 10 people)

Hot flushes, injection site pain and redness. Side effects at the injection site are most common with the

starting dose and less common with the maintenance dose.

Common (may affect up to 1 in 10 people)

injection site swelling, node and hardness

chills, fever or influenza-like illness after the injection

trouble sleeping, tiredness, dizziness, headache

increased weight, nausea, diarrhoea, elevated levels of some liver enzymes

excessive sweating (including night sweats), rash

anaemia

musculoskeletal pain and discomfort

reduced size of testicles, breast swelling, impotence

Uncommon (may affect up to 1 in 100 people)

loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain

depression, mental impairment

skin redness, loss of hair, skin nodule, numbness

allergic reactions, hives, itching

decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood

sugar/diabetes mellitus, increased cholesterol, changes in blood calcium, decreased weight

high blood pressure, changes in heart rhythm, changes in ECG (QT-prolongation), feeling of abnormal

heart beat, dyspnoea, peripheral oedema

muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint

frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at

night, impaired renal function, incontinence

blurred vision

discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction)

malaise

Rare (may affect up to 1 in 1,000 people)

febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart

failure

Very rare (may affect up to 1 in 10,000 people)

injection site infection, abscess and necrosis

Reporting of side effects

If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By

reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store FIRMAGON

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 vials, syringes and outer packaging. The

expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

After reconstitution:

This medicine is stable for 2 hours at 25ºC.

Due to the risk of microbial contamination, this medicine should be used immediately. If not used

immediately, the use of this medicine are the responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What FIRMAGON contains

The active substance is degarelix, each vial contains 80 mg degarelix (as acetate). After reconstitution

1 ml of the reconstituted solution contains 20 mg degarelix.

The other ingredient of the powder is mannitol (E 421).

The solvent is water for injections.

What FIRMAGON looks like and contents of the pack

FIRMAGON is a powder and solvent for solution for injection. The powder is white to off-white. The

solvent is a clear, colourless solution.

FIRMAGON is available in 2 pack-sizes.

Pack-size of 1 tray containing:

1 vial with powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent.

1 plunger rod, 1 vial adapter and 1 injection needle.

Pack-size of 3 trays containing:

3 vials with powder containing 80 mg of degarelix and 3 pre-filled syringes with 4.2 ml of solvent.

3 plunger rods, 3 vial adapters and 3 injection needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

DK-2300 Copenhagen S

Denmark

Tel. +45 8833 8834

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Ferring N.V.

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Lietuva

CentralPharma Communication UAB

Tel: +370 5 243 0444

centralpharma@centralpharma.lt

България

Аквaxим АД

Тел: +359 2 807 5022

aquachim@aquachim.bg

Luxembourg/Luxemburg

Ferring N.V.

Belgique/Belgien

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Česká republika

Ferring Pharmaceuticals CZ s.r.o.

Tel: +420 234 701 333

cz1-info@ferring.com

Magyarország

Ferring Magyarország Gyógyszerkereskedelmi Kft.

Tel: +36 1 236 3800

ferring@ferring.hu

Danmark

Ferring Lægemidler A/S

Tlf: +45 88 16 88 17

Malta

E.J. Busuttil Ltd.

Tel: +356 21447184

info@ejbusuttil.com

Deutschland

Ferring Arzneimittel GmbH

Tel: +49 431 5852 0

info-service@ferring.de

Nederland

Ferring B.V.

Tel: +31 235680300

infoNL@ferring.com

Eesti

CentralPharma Communication OÜ

Tel: +372 601 5540

Norge

Ferring Legemidler AS

Tlf: +47 22 02 08 80

centralpharma@centralpharma.ee

mail@oslo.ferring.com

Ελλάδα

Ferring Ελλάς MEΠΕ

Τηλ: +30 210 68 43 449

Österreich

Ferring Arzneimittel Ges.m.b.H.

Tel: +43 1 60 8080

office@ferring.at

España

Ferring S.A.U.

Tel: +34 91 387 70 00

registros@ferring.com

Polska

Ferring Pharmaceuticals Poland Sp. z o.o.

Tel: +48 22 246 06 80

ferring@ferring.pl

France

Ferring S.A.S.

Tél: +33 1 49 08 67 60

information.medicale@ferring.com

Portugal

Ferring Portuguesa – Produtos Farmacêuticos,

Sociedade Unipessoal, Lda.

Tel: +351 21 940 51 90

geral@ferring.com

Hrvatska

Clinres farmacija d.o.o.

Tel: +385 1 2396 900

România

Ferring Pharmaceuticals Romania SRL

Tel: +40 356 113 270

Ireland

Ferring Ireland Ltd.

Tel: +353 1 4637355

enquiries.ireland@ferring.com

Slovenija

SALUS, Veletrgovina, d.o.o.

Tel: +386 1 5899 179

regulatory@salus.si

Ísland

Vistor hf.

Sími: +354 535 70 00

Slovenská republika

Ferring Slovakia s.r.o.

Tel: +421 2 54 416 010

SK0-Recepcia@ferring.com

Italia

Ferring S.p.A.

Tel: +39 02 640 00 11

Suomi/Finland

Ferring Lääkkeet Oy

Puh/Tel: +358 207 401 440

info@ferring.fi

Κύπρος

A. Potamitis Medicare Ltd

Τηλ: +357 22583333

a.potamitismedicare@cytanet.com.cy

Sverige

Ferring Läkemedel AB

Tel: +46 40 691 69 00

info@ferring.se

Latvija

CentralPharma Communication SIA

Tālr: +371 674 50497

centralpharma@centralpharma.lv

United Kingdom

Ferring Pharmaceuticals Ltd.

Tel: +44 844 931 0050

contact2@ferring.com

This leaflet was last revised in

{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for proper use

NOTE:

DO NOT SHAKE THE VIALS

The pack contains one vial of powder and one pre-filled syringe with solvent that must be prepared for

subcutaneous injection.

1.

Remove the cover from the vial adapter pack.

Attach the adapter to the powder vial by pressing

the adapter down until the spike pushes through

the rubber stopper and the adapter snaps in place.

2.

Prepare the pre-filled syringe by attaching the plunger rod.

3.

Remove the cap of the pre-filled syringe. Attach

the syringe to the powder vial by screwing it on

to the adapter.

Transfer all solvent to the

powder vial.

4.

With the syringe still attached to the adapter, swirl

gently until the liquid looks clear and without

undissolved powder or particles. If the powder

adheres to the side of the vial above the liquid

surface, the vial can be tilted slightly.

Avoid shaking

to prevent foam formation.

A ring of small air bubbles on the surface of the

liquid is acceptable. The reconstitution procedure

usually takes a few minutes, but may take up to 15

minutes in some cases.

5.

Turn the vial upside down and draw up to the line

mark on the syringe for injection.

Always make sure to withdraw the precise

volume

and adjust for any air bubbles

.

6.

Detach the syringe from the vial adapter and attach the needle for deep subcutaneous

injection to the syringe.

7.

Perform a deep subcutaneous injection. To do so:

grasp the skin of the abdomen, elevate the

subcutaneous tissue and insert the needle deeply at

an angle of

not less than 45 degrees.

Inject

4 ml of FIRMAGON 80 mg

slowly,

immediately after reconstitution.*

8.

No injections should be given in areas where the patient will be exposed to pressure, e.g.

around the belt or waistband or close to the ribs.

Do not inject directly into a vein. Gently pull back the plunger to check if blood is

aspirated. If blood appears in the syringe, the medicinal product can no longer be used.

Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose

for the patient).

Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a

microbiological point of view, unless the method of reconstitution precludes the risk of microbial

contamination, the product should be used immediately. If not used immediately, in-use storage times

and conditions are the responsibility of the user.

Package leaflet: Information for the user

FIRMAGON 120 mg powder and solvent for solution for injection

Degarelix

Read all of this leaflet carefully before you start using this medicine because it contains important

information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet:

What FIRMAGON is and what it is used for

What you need to know before you use FIRMAGON

How to use FIRMAGON

Possible side effects

How to store FIRMAGON

Contents of the pack and other information

1.

What FIRMAGON is and what it is used for

FIRMAGON contains degarelix.

Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients.

Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its

effects. By doing so, degarelix immediately reduces the level of the male hormone testosterone that

stimulates the prostate cancer.

2.

What you need to know before you use FIRMAGON

Do not use FIRMAGON

If you are allergic to degarelix or any of the other ingredients this medicine (listed in section 6).

Warnings and precautions

Please tell your doctor if you have any of the following:

Any cardiovascular conditions or heart rhythm problems (arrythmia), or are being treated with medicines

for this condition. The risk of heart rhythm problems may be increased when using FIRMAGON.

Diabetes mellitus. Worsening or onset of diabetes may occur. If you have diabetes, you may have to

measure blood glucose more frequently.

Liver disease. Liver function may need to be monitored.

Kidney disease. Use of FIRMAGON has not been investigated in patients with severe kidney disease.

Osteoporosis or any condition that affects the strenght of your bones. Reduced level of testosterone may

cause a reduction in bone calcium (thinning of bones). Severe hypersensitivity. Use of FIRMAGON has

not been investigated in patients with severe hypersensitivity reactions.

Children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and FIRMAGON

FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine,

procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g.

methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic),

antipsychotics ).

Tell your doctor if you are taking, have recently taken or might take any other medicines, including

medicines obtained without a prescription.

Driving and using machines

Tiredness and dizziness are common side effects that may impair your ability to drive and use machines.

These side effects may be due to the treatment or effects resulting from the underlying disease.

3.

How to use FIRMAGON

This medicine is usually injected by a nurse or a doctor.

The recommended starting dose is two consecutive injections of 120 mg After that, you will receive a

monthly 80 mg injection. The injected liquid forms a gel from which degarelix is released over a period of

one month.

FIRMAGON must be injected under the skin (subcutaneously) ONLY. FIRMAGON must NOT be given

into a blood vessel (intravenously). Precautions must be taken to avoid accidental injection into a vein. The

site of injection is likely to vary within the abdominal region.

If you forget to use FIRMAGON

If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

A very serious allergic reaction to this medicine is rare. Seek medical advice straight away if you develop a

severe rash, itching or shortness of breath or difficulty breathing. These could be symptoms of a severe

allergic reaction.

Very common (may affect more than 1 in 10 people)

Hot flushes, injection site pain and redness. Side effects at the injection site are most common with the

starting dose and less common with the maintenance dose.

Common (may affect up to 1 in 10 people)

injection site swelling, node and hardness

chills, fever or influenza-like illness after the injection

trouble sleeping, tiredness, dizziness, headache

increased weight, nausea, diarrhoea, elevated levels of some liver enzymes

excessive sweating (including night sweats), rash

anaemia

musculoskeletal pain and discomfort

reduced size of testicles, breast swelling, impotence

Uncommon (may affect up to 1 in 100 people)

loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain

depression, mental impairment

skin redness, loss of hair, skin nodule, numbness

allergic reactions, hives, itching

decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood

sugar/diabetes mellitus, increased cholesterol, changes in blood calcium, decreased weight

high blood pressure, changes in heart rhythm, changes in ECG (QT-prolongation), feeling of abnormal

heart beat, dyspnoea, peripheral oedema

muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint

frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at

night, impaired renal function, incontinence

blurred vision

discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction)

malaise

Rare (may affect up to 1 in 1,000 people)

febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart

failure

Very rare (may affect up to 1 in 10,000 people)

injection site infection, abscess and necrosis

Reporting of side effects

If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By

reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store FIRMAGON

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 vials, syringes and outer packaging. The

expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

After reconstitution

This medicine is stable for 2 hours at 25ºC.

Due to the risk of microbial contamination, this medicine should be used immediately. If not used

immediately, the use of this medicine are the responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What FIRMAGON contains

The active substance is degarelix. Each vial contains 120 mg degarelix (as acetate). After reconstitution

1 ml of the reconstituted solution contains 40 mg degarelix.

The other ingredient of the powder is mannitol (E 421).

The solvent is water for injections.

What FIRMAGON looks like and contents of the pack

FIRMAGON is a powder and solvent for solution for injection. The powder is white to off-white. The

solvent is a clear, colourless solution.

Pack-size of 2 trays containing:

2 vials with powder containing 120 mg of degarelix and 2 pre-filled syringes with 3 ml of solvent.

2 plunger rods, 2 vial adapters and 2 injection needles.

Marketing Authorisation Holder

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

DK-2300 Copenhagen S

Denmark

Tel. +45 8833 8834

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Ferring N.V.

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Lietuva

CentralPharma Communication UAB

Tel: +370 5 243 0444

centralpharma@centralpharma.lt

България

Аквaxим АД

Тел: +359 2 807 5022

aquachim@aquachim.bg

Luxembourg/Luxemburg

Ferring N.V.

Belgique/Belgien

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Česká republika

Ferring Pharmaceuticals CZ s.r.o.

Tel: +420 234 701 333

cz1-info@ferring.com

Magyarország

Ferring Magyarország Gyógyszerkereskedelmi Kft.

Tel: +36 1 236 3800

ferring@ferring.hu

Danmark

Ferring Lægemidler A/S

Tlf: +45 88 16 88 17

Malta

E.J. Busuttil Ltd.

Tel: +356 21447184

info@ejbusuttil.com

Deutschland

Ferring Arzneimittel GmbH

Tel: +49 431 5852 0

info-service@ferring.de

Nederland

Ferring B.V.

Tel: +31 235680300

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Ferring Legemidler AS

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mail@oslo.ferring.com

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Tel: +43 1 60 8080

office@ferring.at

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Ferring Pharmaceuticals Poland Sp. z o.o.

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ferring@ferring.pl

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Ferring Ireland Ltd.

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This leaflet was last revised in

{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for proper use

NOTE:

DO NOT SHAKE THE VIALS

The pack contains two vials of powder and two pre-filled syringes with solvent that must be prepared for

subcutaneous injection. Hence, the procedure described below need to be repeated a second time.

1.

Remove the cover from the vial adapter pack.

Attach the adapters to the powder vial by

pressing the adapter down until the spike

pushes through the rubber stopper and the

adapter snaps in place.

2.

Prepare the pre-filled syringe by attaching the plunger rod.

3.

Remove the cap of the pre-filled syringe. Attach

the syringe to the powder vial by screwing it on

to the adapter.

Transfer all solvent to the

powder vial.

4.

With the syringe still attached to the adapter,

swirl gently until the liquid looks clear and without

undissolved powder or particles. If the powder

adheres to the side of the vial above the liquid

surface, the vial can be tilted slightly.

Avoid

shaking to prevent foam formation.

A ring of small air bubbles on the surface of the

liquid is acceptable. The reconstitution procedure

usually takes a few minutes, but may take up to 15

minutes in some cases.

5

. Turn the vial upside down and draw up to the line

mark of the syringe for injection.

Always make sure to withdraw the precise

volume

and adjust for any air bubbles

.

6

. Detach the syringe from the vial adapter and attach the needle for deep subcutaneous

injection to the syringe.

7.

Perform a deep subcutaneous injection. To do so:

grasp the skin of the abdomen, elevate the

subcutaneous tissue and insert the needle deeply at

an angle of

not less than

45 degrees.

Inject

3 ml of FIRMAGON 120 mg

slowly,

immediately after reconstitution.*

8.

No injections should be given in areas where the patient will be exposed to pressure, e.g.

around the belt or waistband or close to the ribs.

Do not inject directly into a vein. Gently pull back the plunger to check if blood is

aspirated. If blood appears in the syringe, the medicinal product can no longer be used.

Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose

for the patient).

9.

Repeat the reconstitution procedure for the second dose. Choose a different injection site

and inject 3 ml.

Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a

microbiological point of view, unless the method of reconstitution precludes the risk of microbial

contamination, the product should be used immediately. If not used immediately, in-use storage times

and conditions are the responsibility of the user.