Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Testosterone undecylate 1000mg;
Bayer New Zealand Limited
Testosterone undecylate 1000 mg
1000 mg/4mL
Solution for injection
Active: Testosterone undecylate 1000mg Excipient: Benzyl benzoate Castor oil
Ampoule, glass, 4 mL - type I glass ampoule 1 x 1,000 mg dose, 1 dose unit
Prescription
Prescription
Bayer AG
Testosterone replacement in primary and secondary male hypogonadism
Package - Contents - Shelf Life: Ampoule, glass, 4 mL - type I glass ampoule 1 x 1,000 mg dose - 1 dose units - 5 years from date of manufacture stored at or below 30°C protect from light - Vial, glass, Amber Type 1 with bromobutyl gray stopper with foil clad ETFE - 1 dose units - 60 months from date of manufacture stored at or below 30°C protect from light
2006-08-14
REANDRON ® 1000 1 RESTRICTED REREANDRON® 1000 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING REANDRON? REANDRON contains the active ingredient testosterone undecanoate . REANDRON is used to replace the body’s testosterone in male hypogonadism a condition where there are low levels of testosterone in the body. For more information, see Section 1. Why am I using REANDRON? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE REANDRON? Do not use if you have ever had an allergic reaction to REANDRON or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS SUCH AS DIABETES, FLUID RETENTION, BLEEDING DISORDERS, HIGH BLOOD PRESSURE, PROSTATE TUMOURS, EPILEPSY OR IF YOU TAKE ANY OTHER MEDICINES For more information, see Section 2. What should I know before I use REANDRON? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with REANDRON and affect how it works. Let your doctor know if you take medicines to thin the blood, control blood sugar levels, suppress the immune system, for pain and inflammation or for treatment of sleeping problems and nervousness. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE REANDRON? REANDRON is injected by your healthcare professional every 10-14 weeks. More instructions can be found in Section 4. How do I use REANDRON? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING REANDRON? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using REANDRON. • Keep all of your doctor’s appointments. Your doctor may monitor your blood pressure, examine your prostate and conduct other tests from time to time. LOOKING AFTER YOUR MEDICINE • Store it in a cool dry place away from moisture, heat or sunlight where the temperature stays below 30°C For more informati Baca dokumen lengkap
Reandron 1000 DS VX3.0; CCDS10 DATA SHEET 1. REANDRON ® 1000 (1000 MG/4 ML SOLUTION FOR INJECTION) Reandron 1000, 1000 mg/ 4 mL solution for injection _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule/vial contains 1000 mg testosterone undecanoate (equivalent to 631.5 mg testosterone) in a 4 mL solution for injection (250 mg testosterone undecanoate/mL). Each mL solution for injection contains 250 mg testosterone undecanoate corresponding to 157.9 mg testosterone. For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Reandron 1000 is a clear, colourless to yellowish-brown oily solution for injection. Testosterone undecanoate is a white or off-white crystalline substance. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Testosterone replacement in primary and secondary male hypogonadism. 4.2 DOSE AND METHOD OF ADMINISTRATION 4.2.1 DOSE Reandron 1000 (1 ampoule/vial equivalent to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks for testosterone replacement, where testosterone deficiency has been confirmed by clinical features and biochemical tests. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation. 4.2.1.1 START OF TREATMENT Serum testosterone levels should be measured before start of treatment and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady-state testosterone levels may be achieved more rapidly. 4.2.1.2 INDIVIDUALISATION OF TREATMENT The injection interval should remain within the recommended range of 10 to 14 weeks. It is advisable to measure and monitor testosterone serum levels regularly, particularly if the dosage regimen is changed or if there is clinical concern about the adequacy or excessiveness of testosterone replacement. Measurements should be performed at Baca dokumen lengkap