Abbreviated prescribing information:
Microrelin 11.25 mg contains active ingredient pharmaceutical triptorelin acetate, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH). The sustained release of drug allows continuous release of the triptorelin acetate over 3 months. Microrelin 11.25 mg injectable suspension for intramuscular use is provided as a sterile, lyophilized, biodegradable microsphere in a single-dose vial.
Advanced hormone dependent prostatic cancer. Other situations where lowering of sex steroid serum levels to castrate level is desired, such as endometriosis, uterine myoma. MICRORELIN ® is used in treatment of confirmed central precocious puberty (girls under 9 years, boys under 10 years).
A Reliable choice for ENDOMETRIOSIS & UTERIN FIBROIDS
Pregnancy should be precluded prior to treatment. Menstruation does not occur during treatment of uterine myomas and endometriosis. During treatment of uterine myomas the size of uterus and myoma should be determined regularly, e.g. by means of ultrasonography. Treatment with MICRORELIN ® over several months can lead to a decrease of bone density so the therapy should not exceed a duration of 6 months.
A Reliable choice for Prostate Cancer
The use of MICRORELIN ® has to be carefully evaluated in patients with premonitory signs of modularly compression and the medical surveillance has to be closer in the first weeks of treatment, particular in patients with spinal metastases. In order to prevent accentuation of the clinical symptoms, supplementary administration of an appropriate antiandrogen agent should be considered in the initial phase of the treatment.
A Reliable choice for central precocious puberty
The chronological age at the beginning of therapy should be under 9 years in girls and under 10 years in boys.
The most commonly observed adverse events during triptorelin treatment are due to the expected physiological effects related to decreased testosterone levels. These effects included hot flushes, erectile dysfunction, and decreased libido. If these conditions are aggravated, it may lead to neurological problems such as weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms. In rare cases allergic reaction or more rarely nausea, vomiting, weight gain, hypertension, mood disorders, visual disturbances, fever or pain at the injection site may occur.
Special precautions for storage:
MICRORELIN ® should be stored between 15-25°C. Keep out of the reach and sight of children.