Cannula :
Due to the injection depth of the implants, it is recommended that Perfectha® SubSkin is injected using an appropriately sized (between 23G and 16G) injection cannula with a rounded tip and side port.
Fitting the cannula :
For safe use of Perfectha® SubSkin it is important that the cannula is correctly fitted:
1. Carefully unscrew the cap from the syringe, taking care to hold the Luer firmly
2. Unscrew the protective cap from the cannula and hold the cannula by the base of its protective cap
3. Gently and manually screw the cannula into the Luer Lock of the syringe until you feel a slight resistance, taking care to hold the Luer firmly.
4. Completely purge the air from the cannula before starting the injection
For a better understanding, follow the instructions given in the illustrations in this leaflet.
The usual precautions associated with the handling of needles and cannulas must be followed. Do not attempt to straighten a bent needle or cannula; it should be discarded. Dispose of used needles and cannulas in appropriate collectors.
Method of administration:
Before starting treatment, it is important to study the suitability of the patient for the chosen treatment (type of correction, medical treatment, other implant, etc...). The patient must be informed of the indications, expected results, contraindications, warnings, precautions and known adverse effects. The area to be treated must first be cleaned and disinfected with an appropriate Anticeptics solution. Perfectha® SubSkin must be administered using a cannula of the appropriate calibre and length for each indication and application area, ensuring that the product is injected exclusively into the subcutaneous regions. Before starting treatment, the need for anaesthesia should be assessed. This can be topical, local by direct infiltration into the subcutaneous tissue or by means of a nerve block. Local anaesthesia is preferable to topical anaesthesia for better pain control. Because of the rounded shape of the cannula, it is necessary to make a pre-incision at the injection site using a hypodermic needle with a diameter equal to or greater than that of the cannula. Before starting the application, carefully push the plunger until a drop of product appears at the end of the cannula, so as to completely purge it of air. The product should be applied to the subcutaneous and supra-periosteal areas. The technique, depth of injection and quantity administered may vary according to the practitioner's assessment. Use the retro-injection technique in a linear, fanning or bolus pattern, depending on the area injected and the desired filling effect. During application, it is recommended that the cannula orifice is turned upwards. Slowly apply the Perfectha® SubSkin implant at the same time as the cannula is slowly withdrawn. The application must be stopped immediately before the cannula is completely removed from the Skin in order to avoid
overflow of the product onto the application area. Results are immediate; the amount applied should correct the defect without producing hypercorrection. The treated area should be lightly massaged so that the product adapts to the underlying tissue. It is not necessary to apply Plasters or any other type of bandage, but its use should be assessed by the practitioner. For each treatment, a maximum dosage of no more than 30 ml per complete session is recommended, without exceeding 60 ml per year. After each application of Perfectha® SubSkin, ice-cold compresses should be applied to the treated area. Perfectha® SubSkin should only be administered by duly trained and authorised doctors, in accordance with local legislation. Follow-up treatment: Subsequent applications of Perfectha® SubSkin may be required to achieve the desired level of correction or to combine the treatment with other products in the Perfectha® range. The Perfectha® SubSkin treatment application technique is important for an optimal final result.
