Leaflet BELKYRA 10mg / ml solution for injection

Product code:
W69267001
Quantity:
4
Indicated for:
submental fat reduction
Route of administration:
injectable
Substance:
deoxycholic acid (bile acid)
ATC
D11AX24 — Dermatologicals | Other dermatological preparations | Other dermatological preparations | Other dermatologicals
Deoxycholic acid is a naturally occurring bile acid primarily used in aesthetic treatments to reduce localized subcutaneous fat, particularly in the chin area (submental fat). It is approved for use in minimally invasive procedures and is known for its ability to destroy fat cells, providing a more defined contour to the face or other treated areas.

The mechanism of action of deoxycholic acid involves the destruction of fat cell membranes. After injection, deoxycholic acid breaks down fat cells, and their contents are gradually eliminated by the body through natural metabolic processes. Once destroyed, fat cells do not regenerate, making the results long-lasting, provided the patient maintains a stable body weight.

Deoxycholic acid is administered as localized injections, and the treatment is typically performed over multiple sessions, depending on the amount of fat to be removed and the patient’s response. The procedure is minimally invasive and does not require surgery, making it a popular option for patients seeking to avoid liposuction.

While effective, treatment with deoxycholic acid may cause some side effects. The most common include swelling, redness, pain, bruising, or numbness at the injection site. In rare cases, more serious complications such as nerve injury or infections may occur. It is important that the treatment is performed by a qualified specialist, and patients should follow post-procedure recommendations to minimize risks.

General data about BELKYRA 10mg / ml

Substance:
deoxycholic acid
Date of latest medicines list:
01-12-2022
Product code:
W69267001
Concentration:
10mg / ml
Pharmaceutical form:
solution for injection
Quantity:
4
Product type:
Original
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD. - IRLANDA
Holder:
ABBVIE LIMITED - IRLANDA
Number:
14147/2021/01
Shelf life:
30 months-after packing for marketing;after the first opening-it is used immediately