Direct healthcare professional communication on the correct method of administration of Reseligo 3.6 mg and 10.8 mg implant in pre-filled syringe (goserelin)
30.08.2016
Alvogen d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED), has informed healthcare professionals of the correct method of administration of Reseligo 3.6 mg and 10.8 mg implant in pre-filled syringe (goserelin). In order to avoid the incorrect administration or discomfort for a patient during and after administration of Reseligo, attention should be paid to specificities of the syringe for application of the medicinal product and of the method of administration of Reseligo, which are different from the syringe and method of administration of the reference medicinal product.
Summary
- When administering Reseligo, the needle is inserted into the subcutaneous tissue obliquely (almost parallel to skin), which differs from the angle at which the reference medicinal product is applied. The needle is inserted until the syringe barrel touches the patient's skin. This contact with the skin must remain during the entire application process.
- In contrast to the reference medicinal product, the syringe for application of Reseligo is equipped with an integrated automatic system for the retraction of the needle from tissue and the protection of healthcare professionals from needle-stick injuries.
- After inserting the needle, the syringe plunger should be pressed down which transfers the implant to the tip of the needle, and the needle is automatically retracted from tissue. The syringe of Reseligo should not be pulled out during application. The syringe barrel must remain in contact with the skin during administration.
- If the syringe of Reseligo is actively retracted from the skin during administration, the administration has not been completed and incorrect use or discomfort for a patient can occur.
Further information
Goserelin is indicated for the treatment of certain patients with prostate cancer and certain female patients with breast cancer, endometriosis or uterine fibroids and is also indicated for endometrial thinning and in preparation of patients for assisted reproduction.
The communication provides healthcare professionals with more detailed information on the characteristics of the needle of Reseligo and the correct method of administration of the medicinal product.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
