PRECAUTIONS, LIMITATIONS AND SIDE EFFECT
Precautions
ATLÉAN® βTCP is only for use by physicians experienced in injecting wrinkle filling agents. Your doctor should have attended a special training course on how to inject ATLÉAN® βTCP.
ATLÉAN® βTCP should be used with caution in patients taking products that affect coagulation (e.g.aspirin) and/or anti-coagulants, as they tend to bleed/bruise more easily at injection sites or be at higher risk of developing a hematoma.
ATLÉAN® βTCP should not be used in the periorbital area or in the lips nor in the forehead.
ATLÉAN® βTCP should not be used by anyone with a history of hypersensitivity to any of its ingredients (See product insert for full list of ingredients).
The benefit/risk of ATLÉAN® βTCP in pregnant or breastfeeding women or in people under 18 years of age has not been established. Therefore ATLÉAN® βTCP should not be used in these populations.
ATLÉAN® βTCP should not be used with patients in chronic or acute skin disease (infectious or inflammatory) in or around the area to be treated.
Side Effects
Injection-related side effects may occur which are common with any injectable gel. Such side effects can be categorized as “early” and occur at time of injection or shortly thereafter or “late” meaning the side effect appears weeks or even months later and are uncommon.
Early phase:
* Short-term pain, tenderness, erythema (redness), bleeding, bruising or hematoma may occur around the injection site.
* Skin blanching may occur during a superficial injection, which usually disappears spontaneously.
Late phase:
* Nodules (lumps or bumps) may occur in the dermis.
* If an injection occurs into the blood vessel, a hematoma may occur and in rare cases this can lead to necrosis.
For further information or to report adverse events* contact our main office at the address below or call your local country using the telephone directory below:
Main Office Contact:
Stiefel Laboratories,
Eurasia Headquarters,
Concorde Road,
Maidenhead
SL6 4BY UK
Fax: 0800 100 11 100
Email: medinfo@stiefel.co.uk
Or email : medicalaffairs@stiefel.com
Telephone Directory by Country:
Canada: (1-514)332 3800
France: (33-1) 41390370
Germany: (49-69)984 0420
Italy: (3902) 213 7606
Singapore: (65) 6417 9500
Peru: 4181800
United Kingdom: (44-0) 628 612000
Spain: (34) 91 691 8280
* If you experience an adverse event please contact your doctor immediately.
Warnings
The concomitant use of ATLÉAN® βTCP with other injectable aesthetic products has not been studied.
Atléan is packaged for single patient use. It should not be re-used or re-sterilised.