Diphereline PR Caution For Usage

Incompatibilities: 3.75 mg: In absence of incompatibility study, this medicinal product should not be taken with other medicinal products.
11.25 mg: Not applicable.
Instructions for use and handling: 3.75 mg: The suspension for injection must be reconstituted using an aseptic technique and only using the ampoule of solvent for injection.
The instructions for reconstitution hereafter and in the leaflet must be strictly followed.
The solvent should be drawn into the syringe provided using the reconstitution needle (20 G, without safety system) and transferred to the vial containing the powder. The suspension should be reconstituted by swirling the vial gently from side to side for long enough until a homogenous, milky suspension is formed. Do not invert the vial.
It is important to check there is no unsuspended powder in the vial. The suspension obtained should then be drawn back into the syringe, without inverting the vial. The reconstitution needle should then be changed and the injection needle (20 G, with safety device) used to administer the product.
As the product is a suspension, the injection should be administered immediately after reconstitution to prevent precipitation.
For single use only.
Used needles, any unused suspension or other waste material should be disposed of in accordance with local requirements.
Special precautions for disposal and handling: 11.25 mg: The powder should be suspended in the specific solvent immediately before injection by shaking the vial gently until a milky homogeneous liquid is obtained (The instructions for reconstitution hereafter and in the leaflet must be strictly followed).
For single use only. Any unused suspension should be discarded.
The powder is to be suspended in 2 mL of mannitol solution: Using the reconstitution needle (without safety device), one of the injection needles, all of the solvent is drawn up into the injection syringe supplied and transferred to the vial containing the powder. The vial should be gently shaken to completely disperse the powder to obtain a homogenous, milky suspension. The suspension obtained is then drawn back into the injection syringe. The injection needle should be changed and the suspension should be injected immediately using the specific needle: the 38 mm length needle (20 G) with safety device for intramuscular injection in the gluteal muscle (men, women, children); the 25 mm length needle (20 G) with safety device for subcutaneous injection in abdomen or thigh (only in men).
The suspension should be discarded if it is not administered immediately after reconstitution. See also Shelf life under Storage.
Used injection needles should be disposed in a designated sharp container. Any remaining product should be discarded.
Used needles, unused suspension or other waste material should be disposed of in accordance with local requirements.