LAVIV - azficel-t injection, suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

AZFICEL-T (UNII: 022461SR75) (AZFICEL-T - UNII:022461SR75)

Tilgjengelig fra:

Fibrocell Technologies, Inc.

INN (International Name):

AZFICEL-T

Sammensetning:

AZFICEL-T 15000000 in 1 mL

Administreringsrute:

INTRADERMAL

Indikasjoner:

LAVIVTM is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established. The efficacy of LAVIV beyond six months has not been established. - Allogeneic use If LAVIV is administered to a patient who is not the individual whose skin was used to produce the LAVIV, serious immunological reactions can occur. Each vial of LAVIV has a unique patient identifier to assist in ensuring that there is no mismatch. - Severe Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, can occur in patients with known hypersensitivity to the ingredients in LAVIV. Do not use LAVIV in patients allergic to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of bovine origin. - Active Infection Injecting LAVIV into areas with skin infections can lead to local or systemic infection. Pregnancy Category C. Animal reprodu

Produkt oppsummering:

LAVIV is intended solely for autologous use. LAVIV is supplied in two vials, each containing approximately 18 million cells in 1.2 milliliters. The vials are packaged together in a tamper-evident biohazard bag and shipped at 2-8°C (36-46°F) inside a temperature-controlled shipping container. The manufacturing process for LAVIV takes approximately 11-22 weeks after receipt of the patient's biopsy samples by the manufacturer. Fibrocell will notify the clinic when each patient's treatment may be scheduled. Storage and Handling

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

LAVIV - AZFICEL-T INJECTION, SUSPENSION
FIBROCELL TECHNOLOGIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAVIV (AZFICEL-T) SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LAVIV
.
LAVIV
. (AZFICEL-T)
SUSPENSION FOR INTRADERMAL INJECTION.
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
LAVIV
(azficel-T) is an autologous cellular product indicated for
improvement of the appearance of moderate to severe
nasolabial fold wrinkles in adults. (1)
The safety and efficacy of LAVIV for areas other than the nasolabial
folds have not been established. (1)
The efficacy of LAVIV beyond six months has not been established. (1)
DOSAGE AND ADMINISTRATION
FOR AUTOLOGOUS INTRADERMAL INJECTION ONLY
ONLY HEALTHCARE PROVIDERS WHO HAVE COMPLETED A FIBROCELL-APPROVED
TRAINING PROGRAM SHOULD ADMINISTER
LAVIV. (2)
Inject LAVIV at 0.1 milliliter per linear centimeter into the
nasolabial fold wrinkles. The recommended treatment regimen
is three treatment sessions at 3-6 week intervals. (2)
DOSAGE FORMS AND STRENGTHS
A single vial of LAVIV contains approximately 18 million autologous
fibroblasts in a 1.2 milliliters suspension, sufficient to
administer 1 milliliter of product. (3)
CONTRAINDICATIONS
Allogeneic use of LAVIV
Allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or
material of bovine origin
Active infection in the facial area
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions can occur with LAVIV. (5.1)
LAVIV can cause bleeding and bruising at the treatment site. (5.2)
Vasculitis has occurred following treatment with LAVIV. (5.3)
Herpes labialis has occurred following treatment with LAVIV. (5.4)
Basal cell cancer has occurred following treatment with LAVIV. (5.5)
Keloid and hypertrophic scarring may occur following post-auricular
skin biopsies or LAVIV injections. (5.6)
Patients with genetic disorders affecting dermal fibroblasts or
formation of normal collagen matrices may have an
abnormal response to LAVIV. (5.7)
Immunosuppr