Medicinal Products

EDEX 10 μg / 1 mL

Generic drug of the therapeutic class: Urology nephrology
Active ingredients: Alprostadil
laboratory: Ucb Pharma SA

Powder and solvent for solution for injection
Box of 2 bicompartment cartridges (with needles) of 1 mL
All forms

Indication

Pharmacological induction of erection.

Dosage EDEX 10 μg / 1 mL Powder and solvent for solution for injection Box of 2 cartridges bicompartiment (with needles) of 1 mL

Dosage:
- The dosage is strictly individual and must be determined beforehand by a test.
- The initial dose is 5 μg.
- In case of insufficient erection this dose will then be increased in increments of 5 μg up to 20 μg, during subsequent administrations.
- The dose should be adjusted to allow the patient to be fully erect 5 to 10 minutes after the injection.
- The erection should not last more than one hour.
- Do not administer more than one injection per day, the maximum rate of injections being two per week with an interval of at least 24 hours between injections.
- The maximum individual dose per injection is 20 μg.
- The first injection must be performed in a medical environment.
- Self-injections into the cavernous body will only be performed after learning the injection technique.
- Once the doctor has explained the mode of injection to his patient and determined the effective dose, self-administrations can be made by the patient at home.
- The patient should only inject the optimal individual dose determined for him.
- The patient should not be allowed to increase his individual dose on his own.
Administration mode :
INTRACAVERNEUS STRICT PATH IN ADULT MAN.
- After preparation of the solution as described under instructions for use, handling and disposal, the injection must be performed aseptically in the cavernous body, on the lateral side, on the right or on the right side. left of the penis.
- Take care not to inject into the veins of the penis or the nerves of the upper side and into the urethra of the lower side.
- The injection should be completed within 5 to 10 seconds and manual compression should be done on the injection site for 2 to 3 minutes.
- Any unused solution must be removed. - For presentations with a single-use delivery device, use a new syringe and a sterile needle for any new injection. The reconstituted solution is intended for single use and should not be re-used for re-injection.

Against indications

- Administration of this form of alprostadil is contraindicated by the venous route.
- Intravenous alprostadil-alfadex should not be administered:
. in subjects with known hypersensitivity to prostaglandins;
. in priapism prone subjects due to certain conditions such as sickle cell disease, multiple myeloma or leukemia;
. in the child.
- The therapeutic indications of this product do not concern the woman. However, due to alprostadil switching to sperm and seminal fluid, treatment should be avoided in a patient whose partner is or may be pregnant.
DO NOT USE BY IV OR IM .

Edex side effects

- The main adverse reactions reported after intravenous injection of alprostadil alfadex were as follows:
. priapism and prolonged erections occasionally;
. erectile pain (burning or penile tension)
. injection site hematoma (more related to the injection technique than with alfadex alprostadil).
- Other side effects have been reported:
. fibrosis, erythema, testicular or perineal pain, penile deviation, hemosiderin deposits in the penis;
. injection into the urethra resulting from a bad injection technique;
. changes in blood pressure, orthostatic hypotension, cardiac arrhythmias,
. dizziness, headache;
. vagal shock, and collapse may be more related to the injection with the pharmacological effects of alprostadil.

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