STRATAGRAFT- allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat cellular sheet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

Viable and Metabolically Active Allogeneic Human NIKS Keratinocytes and Human Dermal Fibroblasts Cellularized Layered Scaffold (UNII: DYB2T93463) (Viable and Metabolically Active Allogeneic Human NIKS Keratinocytes and Human Dermal Fibroblasts Cellularized Layered Scaffold - UNII:DYB2T93463)

Հասանելի է:

Stratatech Corporation

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

STRATAGRAFT is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). Do not use in patients with known allergies to murine collagen or products containing ingredients of bovine or porcine origin [See Description (11)]. Risk Summary There are no available data regarding STRATAGRAFT use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with STRATAGRAFT to assess whether it can cause fetal harm when administered to a pregnant woman. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary There is no information available on the presence of STRATAGRAFT in human milk, the effect on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for STRATAGRAFT and any potential adverse effects on the breast-fed infant from STRATAGRAFT or from the underlying maternal condition. The safety and effectiveness of STRATAGRAFT in pediatric patients (< 18 years) have not been established. Eight patients aged 65 years and older were enrolled in Study 1. Although no differences in safety or efficacy were observed between patients aged 65 years and older and younger patients, the number of patients aged 65 years and older was not sufficient to determine whether they responded differently from younger patients.

Ապրանքի ամփոփագիր:

STRATAGRAFT is an approximately 100 cm2 rectangular sheet (approximately 8 cm by 12.5 cm) – (NDC 73612-200-01), loosely adherent to a polycarbonate membrane within a polystyrene frame and packaged in a sealed foil pouch contained within a carton. STRATAGRAFT is shipped on dry ice. The Hold Solution and Hold Dish are packaged separately and shipped at ambient temperature. Store STRATAGRAFT between -70°C and -90°C (-94°F to -130°F). Store the Hold Solution between 2°C and 8°C (36°F and 46°F). Store Hold Dishes at ambient temperature. Do not use any of the above components if they have been compromised. Dispose of unused STRATAGRAFT as surgical biohazardous waste in accordance with local requirements. Dispose of materials that have come into contact with STRATAGRAFT as surgical biohazardous waste in accordance with local requirements. Contact Customer Care at 1-877-647-2239 for further instructions.

Լիազորման կարգավիճակը:

Biologic Licensing Application

Ապրանքի հատկությունները

STRATAGRAFT- ALLOGENEIC CULTURED KERATINOCYTES AND DERMAL FIBROBLASTS
IN
MURINE COLLAGEN-DSAT CELLULAR SHEET
STRATATECH CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STRATAGRAFT SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STRATAGRAFT.
STRATAGRAFT (ALLOGENEIC CULTURED KERATINOCYTES AND DERMAL FIBROBLASTS
IN MURINE COLLAGEN-
DSAT), FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Warnings and Precautions (5.4)
01/2024
INDICATIONS AND USAGE
STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts
in murine collagen-dsat) is an
allogeneic cellularized scaffold product indicated for the treatment
of adults with thermal burns containing
intact dermal elements for which surgical intervention is clinically
indicated (deep partial-thickness burns).
(1)
DOSAGE AND ADMINISTRATION
FOR TOPICAL APPLICATION ONLY.
STRATAGRAFT is applied to a surgically prepared wound bed. The number
of STRATAGRAFT constructs
applied will vary depending on the size of the wound bed. STRATAGRAFT
constructs may be trimmed to
accommodate the size and shape of the wound bed. Each STRATAGRAFT
construct is for application to a
single patient only. (2.1)
DOSAGE FORMS AND STRENGTHS
STRATAGRAFT is an off-white rectangular sheet of approximately 100 cm
(approximately 8 cm by 12.5
cm), consisting of a viable, bioengineered, allogeneic cellularized
scaffold product derived from
keratinocytes grown on gelled collagen containing dermal fibroblasts.
(3)
CONTRAINDICATIONS
Do not use in patients with known allergies to murine collagen or
products containing ingredients of bovine
or porcine origin. (4)
WARNINGS AND PRECAUTIONS
Potential Sensitivity (5.1)
Hypersensitivity Reactions (5.2)
Transmission of Infectious Diseases (5.3)
Donation of Blood, Organs, Tissues, or Cells (5.4)
ADVERSE REACTIONS
The most common (≥2%) adverse reactions were itching (pruritus),
blisters, hypertrophic scar, and
impaired healing. (6.1)
TO REPORT SUSPECTED AD