The composition may be subject to variations, so we advise you to always check the list on the purchased product.
COMPOSITION :
Hyaluronic Acid .............................................................15 mg
Lidocaine hydrochloride ...................................................3 mg
Phosphate buffer pH 7.3 .........................................qsp 1 mL
Contraindications
TEOSYAL® RHA 1 must not be used:
- For injections other than intradermal injections,
- In association with peeling, laser or ultrasound treatment,
- If the patient suffers from skin disease, inflammation or infection in or near the area to be treated,
- In the case of patients with a known hypersensitivity to Hyaluronic Acid, with a history of severe allergies or anaphylactic shock,
- In the case of known hypersensitivity to lidocaine and/or amide-type local anaesthetics,
- in patients suffering from autoimmune diseases,
- in patients suffering from heart disease and/or undergoing treatment for heart disease (beta-blockers),
- in patients with hepatocellular insufficiency and/or undergoing treatment for liver disease
- for people with epilepsy or porphyria,
- as interactions with other filling implants have not been studied, it is not recommended to inject TEOSYAL® RHA 1 in the presence of other filling implants, in the perimeter or on the area to be injected,
- in pregnant or Milk feeding women, or in Children,
- in patients with dark circles with bags (existence of a fat hernia).
Do not inject into blood vessels.
Do not inject into the eyelids.
Sportsmen and women should be warned that this product contains an active compound which may produce a positive reaction in anti-doping tests.
Side effects
The practitioner must inform the patient that there are potential side effects associated with the implantation of this device, which may occur immediately after injection or may be delayed. These include (but are not limited to)
- Local manifestations: inflammatory reactions (erythema, oedema, pain at the injection site), haematomas, itching, temporary loss of sensitivity around the injected area, dyschromia, abscesses, indurations, nodules (which may be granulomas).
- General manifestations: immediate hypersensitivity up to and including anaphylactic shock, migration of the implant.
Rare but serious adverse reactions associated with intravascular injection of fillers in the Face have been reported and include visual disturbances, even temporary or permanent blindness, skin necrosis and stroke.
The patient must also inform the practitioner of any side-effects other than those described above, or of any side-effects persisting beyond one week.
The practitioner will in turn inform the retailer of the product as soon as possible.
Precautions for use
The practitioner must take into account the presence of lidocaine in this filling product. Check the expiry date and the integrity of the packaging before use. Do not use if the expiry date has passed or if the packaging is damaged. Patients should be advised not to take high doses of vitamin E, aspirin, anti-inflammatory drugs or anticoagulants during the week prior to the injection session. Patients should be advised not to wear make-up for twelve hours after the injection and not to expose themselves to extreme temperatures (intense cold, sauna, etc.) for a week after the treatment. At the end of the treatment session, it is essential to dispose of any unused product. This device is for single use only. If it is re-used, sterility is no longer guaranteed, the gel may have deteriorated, reducing its efficiency, and the gel may have dried, making it difficult to extrude through a needle. Dispose of used needles in appropriate containers.
Storage conditions
Store between 2°C and 25°C, away from direct sunlight
The list of ingredients may be subject to variations. We advise you to always check the list on the product purchased.
