Severe hypersensitivity. The use of FIRMAGON has not been studied in patients with severe hypersensitivity reactions.<\/li><\/ul>\n\n\n\nChildren and young people<\/h2>\n\n\n\n Do not give this medicine to children or adolescents.<\/p>\n\n\n\n
Other drugs and FIRMAGON<\/h2>\n\n\n\n FIRMAGON can affect certain medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or other medicines that can affect the heart rhythm (eg methadone (used for pain relief and detoxification), cisapride, moxifloxacin (an antibiotic ), antipsychotics).
Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n Fatigue and dizziness are common side effects that can impair your ability to drive or use machines. These side effects can be caused by the treatment or be a symptom of the disease.
3. How to use FIRMAGON<\/h2>\n\n\n\n This medicine is usually injected by a nurse or doctor.
The recommended starting dose is two injections of 120 mg. You will then receive an injection of 80 mg per month. The injected liquid forms a gel from which degarelix is \u200b\u200breleased for one month.
FIRMAGON should ONLY be injected under the skin ( subcutaneously ). FIRMAGON must NOT be given into a blood vessel ( intravenously ). Precautions must be taken to avoid accidental injection into a vein. The injection site varies within the abdominal area.<\/p>\n\n\n\n
If you forget to use FIRMAGON<\/h2>\n\n\n\n Talk to your doctor if you think your monthly dose of FIRMAGON has been missed.<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them.<\/p>\n\n\n\n
Very severe allergic reactions are rare with this medicine. If you experience severe rash, itching, and difficulty breathing, this may be a symptom of a severe allergic reaction.
Very common (may affect more than 1 user in 10)<\/em><\/p>\n\n\n\nHot flashes, pain, and redness at the injection site. Side effects at the injection site are more common with the starting dose than with the maintenance dose.
Common (may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\nswelling, nodules, and calluses at the injection site<\/li> chills, fever, or flu-like symptoms after injection one<\/li> sleep problems, fatigue, dizziness, headache<\/li> weight gain, nausea, diarrhea, elevated liver enzyme levels<\/li> increased sweating (including night sweats), skin rash<\/li> anemia ( anemia )<\/li> pain and discomfort in muscles and bones<\/li> decreased testicle size, breast swelling, impotence<\/li><\/ul>\n\n\n\nUncommon (may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\nloss of sexual drive, pain in the testicles, pelvic pain, failure to ejaculate, irritation of the genitals, chest pain<\/li> depression, mental deterioration<\/li> skin redness, hair loss, nodules in the skin, loss of sensation<\/li> allergic reactions, hives, itching<\/li> decreased appetite, constipation, vomiting, dry mouth, abdominal pain, stomach upset, high blood sugar\/diabetes, increased cholesterol, changes in calcium in the blood, weight loss<\/li> high blood pressure, changes in heart rate, changes in ECG ( QT prolongation), feeling of irregular heartbeat, shortness of breath, swollen hands, and feet<\/li> muscle weakness, muscle twitching, swollen \/ stiff joints, osteoporosis\/bone deficiency, sore joints<\/li> frequent and urgent urination, difficulty urinating, painful urination, nocturnal urination, impaired renal function, incontinence<\/li> dimsyn<\/li> injection discomfort including a drop in blood pressure and slow heart rate (vasovagal reaction)<\/li> feeling sick<\/li><\/ul>\n\n\n\nRare (may affect up to 1 in 1,000 people)<\/em><\/p>\n\n\n\nneutropenic fever (a very low white blood cell count in combination with fever), heart attack, and heart failure.<\/li><\/ul>\n\n\n\nVery rare (may affect up to 1 in 10,000 people)<\/em><\/p>\n\n\n\ninfection, abscess, or necrosis (local tissue death) at the injection site<\/li><\/ul>\n\n\n\n5. How to store FIRMAGON<\/h2>\n\n\n\n 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 carton, vial, and syringe. The expiration date is the last day of the specified month.
No special storage instructions.
After preparation<\/em><\/p>\n\n\n\nThis medicine can be stored for 2 hours at 25 \u00b0 C.<\/p>\n\n\n\n
Due to the risk of microbiological contamination, this medicine should be used immediately. If not used immediately, the use of this medicinal product is the responsibility of the user.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\nThe active substance is degarelix. Each vial contains 80 mg of degarelix (as acetate). 1 ml reconstituted solution contains 20 mg degarelix.<\/li> The other ingredient in the powder is mannitol (E421).<\/li> The fluid consists of water for injections.<\/li><\/ul>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n FIRMAGON is a powder and solvent for solution for injection. The powder is white to off-white. The solvent is a clear, colorless solution.
FIRMAGON is available in 2 packaging chairs.
Pack size of 1 tray containing:<\/em><\/p>\n\n\n\n1 vial of powder containing 80 mg degarelix, 1 pre-filled syringe with 4.2 ml diluent, 1 syringe plunger, 1 vial adapter, 1 syringe
Pack size of 3 trays containing:<\/em><\/p>\n\n\n\n3 vials containing 80 mg degarelix and 3 pre-filled syringes with 4.2 ml of diluent. 3 plungers, 3 adapters to the vial, and 3 needles.
Not all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n Ferring Pharmaceuticals A \/ S<\/p>\n\n\n\n
Kay Fiskers Square 11<\/p>\n\n\n\n
DK-2300 Copenhagen S<\/p>\n\n\n\n
Denmark<\/p>\n\n\n\n
Tel: +45 88 33 88 34
Manufacturer<\/strong><\/p>\n\n\n\nFerring GmBH<\/p>\n\n\n\n
Wittland 11<\/p>\n\n\n\n
D-24109 Kiel<\/p>\n\n\n\n
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>Ferring NVTel \/ Tel: + 32-53 72 92 00ferringnvsa@ferring.be<\/td>Lithuania<\/strong>CentralPharma Communication UABTel .: +370 5 243 0444centralpharma@centralpharma.lt<\/td><\/tr>Bulgaria<\/strong>Akvaxim ADTel: +359 2 807 5022aquachim@aquachim.bg<\/td>Luxembourg \/ Luxemburg<\/strong>Ferring NVBelgium \/ BelgiumTel \/ Tel: + 32-53 72 92 00ferringnvsa@ferring.be<\/td><\/tr>Czech Republic<\/strong>Ferring Pharmaceuticals CZ sroTel: +420 234 701 333cz1-info@ferring.com<\/td>Hungary<\/strong>Ferring Magyarorsz\u00e1g Gy\u00f3gyszerkereskedelmi Kft.Tel .: +36 1 236 3800ferring@ferring.hu<\/td><\/tr>Denmark<\/strong>Ferring L\u00e6gmedel A \/ STel: +45 88 16 88 17<\/td>Malta<\/strong>EJ Busuttil LtdTel: +356 21447184info@ejbusuttil.com<\/td><\/tr>Germany<\/strong>Ferring Arzneimittel GmbHTel: + 49- (0) 431-5852 0info-service@ferring.de<\/td>The Netherlands<\/strong>Ferring BVTel: + 31-235680300infoNL@ferring.com<\/td><\/tr>Eesti<\/strong>CentralPharma Communication O\u00dcTel: +372 601 5540centralpharma@centralpharma.ee<\/td>Norway<\/strong>Ferring Legmiddel ASTel: +47 22 02 08 80mail@oslo.ferring.com<\/td><\/tr>Greece<\/strong>Ferring \u03a0\u0395\u03bb\u03bb\u03ac\u03c2 ME\u03a0\u0395:\u0397\u03bb: +30 210 68 43 449<\/td>Austria<\/strong>Ferring Pharmaceuticals GesmbHTel: +43 1 60 808 0office@ferring.at<\/td><\/tr>Spain<\/strong>Ferring, SAUTel: +34 91 387 70 00Registros@ferring.com<\/td>Poland<\/strong>Ferring Pharmaceuticals Poland Sp. ZooTel .: +48 22 246 06 80ferring@ferring.pl<\/td><\/tr>France<\/strong>Ferring SASTel: +33 1 49 08 67 60information.medicale@ferring.com<\/td>Portugal<\/strong>Ferring Portuguesa – Pharmaceutical Products, Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90geral@ferring.com<\/td><\/tr>Croatia<\/strong>Clinres pharmacy dooTel: +385 1 2396 900info@clinres-farmacija.hr<\/td>Romania<\/strong>Ferring Pharmaceuticals Romania SRLTel: +40 356 113 270<\/td><\/tr>Ireland<\/strong>Ferring Ireland Ltd.Tel: +353 (0) 1 4637355inquiries.ireland@ferring.com<\/td>Slovenia<\/strong>SALUS, Veletrgovina, dooTel: +386 1 5899 179regulatory@salus.si<\/td><\/tr>Iceland<\/strong>Vistor hf.Phone: +354 535 70 00<\/td>Slovak Republic<\/strong>FERRING Slovakia sroTel: +421 2 54 416 010SK0-Recepcia@ferring.com<\/td><\/tr>Italy<\/strong>Ferring SpATel: +39 02 640 00 11<\/td>Finland \/ Finland<\/strong>Ferring L\u00e4\u00e4kkeet OyPuh \/ Tel: + 358-207 401440info@ferring.fi<\/td><\/tr>Latvia<\/strong>CentralPharma Communication SIAPhone: +371 674 50497centralpharma@centralpharma.lv<\/td>United Kingdom<\/strong>Ferring Pharmaceuticals LtdTel: +44 844 931 0050contact@ferring.co.uk<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":" 80 mg powder and solvent for injection, solution