Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Goserelin acetate 11.34mg equivalent to 10.8 mg goserelin; ; Bicalutamide 50mg
AstraZeneca Limited
Goserelin acetate 11.34 mg (equivalent to 10.8 mg goserelin)
10.8mg+50mg pack
Combination
Active: Goserelin acetate 11.34mg equivalent to 10.8 mg goserelin Excipient: Polyglactin Active: Bicalutamide 50mg Excipient: Hypromellose Lactose Macrogol 300 Magnesium stearate Povidone Sodium starch glycolate Titanium dioxide
Blister pack, PVC/Al, 84 tablets
Prescription
Prescription
AstraZeneca UK Ltd
ZOLACOS CP is indicated for the treatment of advanced prostate cancer and prevention of disease flare associated with the use of LHRH agonists.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 84 tablets - 5 years from date of manufacture stored at or below 30°C - Combination pack, 1 x 10.8 mg Zoladex depot implant + 84 Cosudex tablets - 1 U - 36 months from date of manufacture stored at or below 25°C - Syringe, Depot implant, pre-filled single dose - 1 implants - 36 months from date of manufacture stored at or below 25°C
2008-05-21
ZolaCos CP CMI 010817 Copyright 1(6) ZOLACOS CP ® COSUDEX® (BICALUTAMIDE) AND ZOLADEX® (GOSERELIN) COMBINATION PACK. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ZOLACOS CP. It does not contain all the information that is known about ZOLACOS CP. It does not take the place of talking to your doctor or pharmacist. Your pharmacist or doctor has weighed the risks of you taking ZOLACOS CP against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZOLACOS CP IS USED FOR ZOLACOS CP combination therapy is the brand name for packs containing ZOLADEX (goserelin) 3.6mg subcutaneous implant plus COSUDEX (bicalutamide) 50mg tablets. ZOLACOS CP is used to treat advanced prostate cancer in men. It is not a cure for prostate cancer. Bicalutamide tablets can also be used to treat disease flare associated with previous goserelin therapy. ZOLACOS CP is a combination pack consisting of an anti-androgen (COSUDEX) medicine and a Luteinising Hormone Releasing Hormone (LHRH) agonist (ZOLADEX). Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens may help the cancer cells to grow. LHRH agonists reduce the level of testosterone in men. ZOLACOS CP interferes with some of the actions of these hormones. ZOLACOS CP should only be taken by men. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR. They may differ from the information in this leaflet. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. ZOLACOS CP is not addictive. ZOLACOS CP is only available with a doctor’s prescription. BEFORE YOU USE ZOLACOS CP _WHEN YOU MUST NOT USE IT _ DO NOT USE ZOLACOS CP IF YOU ARE A WOMAN OR A CHILD. DO NOT USE ZOLACOS CP IF YOU ARE ALLERGIC TO BICALUTAMIDE, GOSERELIN OR ANY OF THE OTHER INGREDIENTS IN ZOLACOS CP. Do not t Læs hele dokumentet
Z OLA C OS CP Data Sheet 010817 Copyright 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Z OLA C OS CP 3.6 mg + 50 mg Combination pack Z OLA C OS CP 10.8 mg + 50 mg Combination pack 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Z OLA C OS CP is a combination therapy containing Zoladex (goserelin) 3.6 mg or 10.8 mg subcutaneous implant plus Cosudex (bicalutamide) 50 mg tablets. BICALUTAMIDE C OSUDEX 50 mg is a white film-coated tablet containing 50 mg bicalutamide and is impressed with CDX50 on one side and a logo on the other. GOSERELIN A sterile, white to cream coloured cylindrical implant in which goserelin acetate (equivalent to 3.6 mg or 10.8 mg of peptide base) is dispersed in a biodegradable matrix. It is supplied in a single dose syringe applicator. The SafeSystem TM incorporates a protective needle sleeve that automatically locks in place following administration of the implant to aid in the prevention of needle stick injury. 3. PHARMACEUTICAL FORM Combination pack. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Z OLA C OS CP is indicated for the treatment of advanced prostate cancer and prevention of disease flare associated with the use of luteinizing-hormone releasing hormone (LHRH) agonists. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULT MALES INCLUDING THE ELDERLY BICALUTAMIDE (Cosudex): One tablet (50 mg) once a day. Treatment with Cosudex should be started at the same time as treatment with Zoladex. GOSERELIN (Zoladex): One 3.6 mg implant of goserelin every 28 days or one 10.8 mg implant of goserelin every 3 months, injected subcutaneously into the anterior abdominal wall. Z OLA C OS CP Data Sheet 010817 Copyright 2 CHILDREN Z OLA C OS CP is contraindicated in children. RENAL AND HEPATIC IMPAIRMENT No dosage adjustment is necessary for patients with renal or hepatic impairment. Increased accumulation of bicalutamide may occur in patients with moderate to severe hepatic impairment (see WARNINGS AND PRECAUTIONS). METHOD OF ADMINISTRATION GOSERELIN (ZOLADEX) For correct administration of Z OLADEX , see inst Læs hele dokumentet