Instruction for Use: 1. PREPARATION OF THE PATIENT BEFORE RECONSTITUTION OF THE MEDICINAL PRODUCT: Prepare the patient by disinfecting the injection site. This operation needs to be performed first because once reconstituted, the drug should be injected immediately.
11.25 mg: The injection site is: For WOMEN and CHILDREN: the buttock (intramuscular administration).
For MEN ONLY: the buttock (intramuscular administration) or the abdomen or thigh (subcutaneous administration).
2. PREPARATION OF THE INJECTION: 3.75 mg: Two needles are provided in the box: Needle 1: a long needle (38mm) without safety device to be used for reconstitution; Needle 2: a long needle (38mm) with safety device to be used for injection.
11.25 mg: Three needles are provided in the box, ONLY TWO are to be used: Needle 1: a long needle (38mm) without safety device to be used for reconstitution in all cases; Needle 2: a long needle (38mm) with safety device to be used for intramuscular injection (Men, Women, Children); Needle 3: a short needle (25mm) with safety device to be used for subcutaneous injection (Men only).
The presence of bubbles on top of the lyophilisate is a normal appearance of the product.
2a. Take out the ampoule containing the solvent. Tap any solution within the tip of the ampoule back to the main body of the ampoule.
Screw Needle 1 (without safety device) on to the syringe. Do not remove the needle protection yet.
Break open the ampoule with dot face up.
Remove the needle protection from Needle 1. Insert the needle in the ampoule and draw up all the solvent into the syringe.
Put aside the syringe containing the solvent.
2b. Take out the vial containing the powder; Tap any powder which has accumulated at the top of the vial back to the bottom of the vial.
Remove the plastic tap on the top of vial.
Take back the syringe containing the solvent and insert the needle through the rubber stopper vertically into the vial. Inject the solvent slowly, so that, if possible, it washes down the entire upper part of the vial.
2c. Pull up Needle 1 above the liquid level. Do not remove the needle from the vial. Reconstitute the suspension by swirling gently from side to side. Do not invert the vial.
Make sure that the agitation is long enough to obtain an homogeneous and milky suspension.
Important: Check there is no unsuspended powder in the vial (if any powder clumps are present, continue swirling until they disappear).
2d. When the suspension is homogeneous, pull down the needle without inverting the vial, draw up all of the suspension. A small amount will remain in the vial and should be discarded. An overfill is included to allow for this loss.
Grasp the coloured hub to disconnect the needle. Remove Needle 1 used for the reconstitution from the syringe. Screw on to the syringe Needle 2.
Move the safety sheath away from the needle and towards the syringe barrel. The safety sheath remains in the position the patient sets.
Remove the needle protection from the needle.
Prime the needle to remove air from the syringe and inject immediately.
3. 3.75 mg: INTRAMUSCULAR INJECTION: To avoid precipitation, inject immediately subcutaneously or intramuscularly.
11.25 mg: INJECTION: WOMEN, CHILDREN: with Needle 2 (long needle) intramuscular injection into the gluteal muscle; MEN: with Needle 2 (long needle) intramuscular injection into the gluteal muscle or; with Needle 3 (short needle) subcutaneous injection into abdomen wall or lateral aspects of thigh. Grasp the skin of abdomen or thigh, elevate the subcutaneous tissue and insert the needle with an angle between 30 and 45 degrees.
4. AFTER USE: Activation of the safety system using a one-handed technique.
Note: Keep the finger behind the tab at all times.
There are two alternatives to activate the safety system.
Method A: push the tab forward with the finger, or;
Method B: push the sheath to a flat surface.
In both cases press down with a firm quick motion until a distinct audible click is heard.
Visually confirm that the needle is fully engaged under the lock.
Used needles, any unused suspension or other waste material should be disposed of in accordance with local requirements.