Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - degarelix

Document Subject

Generated Narrative: MedicinalProductDefinition mpf812f9eb1d2ca77fff87e615574ce4dc

identifier: http://ema.europa.eu/identifier/EU/1/23/1753/001-002 (80 mg)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Degarelix Accord 80 mg powder and solvent for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f812f9eb1d2ca77fff87e615574ce4dc

identifier: http://ema.europa.eu/identifier/EU/1/23/1753/001-002 (80 mg)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - degarelix

Attesters

What is in this leaflet:

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

Degarelix Accord contains degarelix.

Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer and for the treatment of high-risk prostate cancer prior to radiotherapy and in combination with radiotherapy 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.

Do not use Degarelix Accord

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 Degarelix Accord.
• 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 Degarelix Accord has not been investigated in patients with severe kidney disease.
• Osteoporosis or any condition that affects the strength of your bones. Reduced level of testosterone may cause a reduction in bone calcium (thinning of bones).
• Severe hypersensitivity. Use of Degarelix Accord 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 Degarelix Accord Degarelix Accord 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.

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.

Degarelix Accord must be injected under the skin (subcutaneously) ONLY. Degarelix Accord 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 Degarelix Accord If you believe your monthly dose of Degarelix Accord has been forgotten, please talk to your doctor. If you have any further questions on the use of this medicine, ask your doctor.

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
• unexplained muscular pain or cramps, tenderness, or weakness. The muscle problems can be serious, including muscle breakdown resulting in kidney damage.

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 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.

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.

Store below 25 C.

After reconstitution: This medicine is stable for 4 hours at 25 C. 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.

What Degarelix Accord 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
• The solvent is water for injections.

What Degarelix Accord looks like and contents of the pack

Degarelix Accord is a powder and solvent for solution for injection. The powder is white or off-white. The solvent is a colourless, clear solution.

Degarelix Accord 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
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6 planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o. ul. Lutomierska 50, 95-200 Pabianice, Poland

Or Laboratori Fundaci Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain

Or Accord Healthcare B.V. Winthontlaan 200, 3526KV Utrecht The Netherlands

Or Pharmadox Healthcare Limited KW20A Kordin Industrial Park, Paola PLA 3000, Malta

This leaflet was last revised in

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