Diphereline PR Dosage/Direction for Use

Strictly comply with the doctor's prescription.
The powder should be suspended in the provided solvent immediately before injection by shaking the vial until a homogeneous liquid is obtained.
Injection should be strictly prepared by following precisely the instructions at the end of this package insert.
Any incomplete injections resulting in the loss of suspension volumes greater than the volume generally remaining in the syringe must be reported.
3.75 mg: Route of administration is strictly intramuscular.
11.25 mg: Route of administration is intramuscular and subcutaneous (for prostate cancer only).
Prostate cancer: 3.75 mg: One intramuscular injection of Diphereline P.R. 3.75mg every 4 weeks.
11.25 mg: One intramuscular or subcutaneous injection of Diphereline P.R. repeated every 3 months.
Endometriosis: The treatment must be initiated in the first five days of the menstrual cycle.
3.75 mg: One Diphereline P.R. 3.75mg intramuscular injection repeated every 4 weeks.
11.25 mg: One intramuscular injection of Diphereline P.R. repeated every 3 months. The subcutaneous administration has not been studied in women.
Treatment duration: This depends on the initial severity of the endometriosis and the changes observed in the clinical features (functional and anatomical) during treatment. It is not recommended to start a second treatment course with triptorelin or by another GnRH analogue.
3.75 mg: In principle, the treatment should not be administered for at least 4 months and for at most 6 months.
11.25 mg: In principle, endometriosis should be treated for at least 3 months and for at most 6 months.
Precocious puberty: The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty.
Treatment should be stopped around the physiological age of puberty in boys and girls and should not be continued in girls with a bone maturation of more than 12 years. There are limited data available in boys relating to the optimum time to stop treatment based on bone age, however it is advised that treatment is stopped in boys with a bone maturation age of 13-14 years.
3.75 mg: Children under 20 kg in body weight: half (1/2) a dose by intramuscular route, every 4 weeks (28 days), i.e. administer half the volume of the reconstituted suspension.
Children between 20 and 30 kg in body weight: two-thirds (2/3) of the dose by intramuscular route, every 4 weeks (28 days), i.e. administer two-thirds of the volume of the reconstituted suspension.
Children over 30 kg in body weight: one intramuscular injection every 4 weeks (28 days), i.e. administer the full volume of reconstituted suspension.
11.25 mg: One intramuscular injection should be administered every 3 months. The subcutaneous administration has not been studied in children.
3.75 mg: Treatment of uterine fibromyomas prior to surgery: One injection of Diphereline P.R. 3.75mg repeated every 4 weeks. The treatment must be initiated in the first five days of the menstrual cycle. Duration of treatment must not exceed 3 months.
NB: The sustained release form must be injected in strict compliance with the instructions given in the package leaflet. Any incomplete injection resulting in the loss of suspension volume greater than the volume generally remaining in the injection device must be reported.
3.75 mg: Breast cancer: One intramuscular injection every 4 weeks in combination with tamoxifen or an aromatase inhibitor.
Triptorelin should be commenced after completion of chemotherapy, once pre-menopausal status has been confirmed.
The treatment with triptorelin must be initiated at least 6-8 weeks before starting aromatase inhibitor treatment. A minimum of two injections of triptorelin (with an interval of 4 weeks between injections) should be administered before commencement of aromatase inhibitor treatment.
During treatment with an aromatase inhibitor, triptorelin must not be interrupted to avoid rebound increases in circulating oestrogens in premenopausal women.
The recommended treatment duration for adjuvant treatment in combination with other hormonotherapy is up to 5 years. Since Diphereline P.R. 3.75 mg is a suspension of microparticles, inadvertent intravascular injection must be strictly avoided.