Facial fat loss ( lipotrophy )

Injection procedure-related adverse reactions-

Brusing      5%  Edema 3%   hematoma  27%

Others-

CNS -   fatigue,  lack of effectiveness,  malaise

Dermatologic-   application site discharge, ectropion,  hypertrophy of the skin.
                           injection-site abcess,  intection -site fat atrophy, injection -site granuloma
                          skn rash, skin roughness

Miscellaneous-   aching joints,  allergic angioedema, brittle nails, hair breakage,
                             hypersensitivity reactions, photosensitivity reactions    

Hypersentivity to the product

Special Precautions-

Skin inflammation- differ use of poly-1-poly Lactic acid in any person with active skin
inflammation or skin infection in or near the treatment areas until the inflammatory or
infectious process has bee controlled.

Administration- should only be administered by health care providers with expertise in the
correction volume defeciences in patients with human immnunodefieciency virus after fully
familiarizing themselves with the product, theproduct educational materials etx.

Safety and efficacy for use in preorbital areas  have not been established

Local effects- njection procedure reactions have been observed, consisting mainly of
hematoma, bruising, edema, discomfort, inflammation and erhyema.
The most common common devise-related adverse reactions - delayed occurance of
subcutaneous papules, confined to injection site and were typically  visible

Long term use-   long term safety and effectiveness  of use beyond 2 years have
not been established

Risk of infections-  poly-L-lactic acid injection carries a risk of infection. Follow standard
precautions associated with injectable materials

Photosensitivity- inform the patient that he or she should minimise exposure of the treated
area to excessive sun or UV lamp exposure until swelling and redness has resolved

Pregnancy- safety for use during pregnancy has not been established

Lactation- safety for use in breast feeding females has not been established

Children- safety for use in pediatric patients younger than 18 years has not been established

Indication-
Facial fat loss ( lipotrophy )

Dosage-
The quanity of ploy-L- -lactic acid and number of injection sesions will vary from by patient.
Treatment for severe fat loss typically requires injection of 1 vial of poly-L-lactic acid per
cheek are per injection session.

1. Within the first 24 hours the patients  should apply ice pack ( avoiding direct contact with the
   skin ) to the treated area to reduce swelling

2. Poly lactic acid may cause redness, swelling, or bruising when injected into the skin, typically
    resolving itself in hours to 1 week

3. Hematoma can occur resolving itself in aporoximately 2 weeks.  Instruct patients to report
    worsening or prolonged symptoms or signs of deterioration to their healt care provider.

4. Insruct patients to massage the treatment area daily for several days following any
    injection session

5. Treatment with poly-Lactic acid can result in small papules in the  treatment area.
    These subcutaneous papules are typically not visible and symptomatic and may
    not be noticed. Advice patients to report any side effects,

6. Make-up can be applied  few hours after postreatment if no complications are present
    eg open wounds, bleeding, redness, swelling.

7. Instruct patients to minimise exposure of the treatment area to excessive sun or UV  lamp
    exposure until any initial swelling has resolved   

Pregnancy-
Safety for use during pregnancy has not been established

Lactation-
Safety for use in breast feeding females has not been established

Children-
Safety for use in pediatric patients younger than 18 years has not been established