Seven Indústria de Produtos Biotecnológicos Ltda.Rua Luiz Carlos Zani, 2783 - Jardim Santa Paula

CEP: 86.200-000 - Ibiporã - Paraná - Brasil

nexfill@gseven.com.br

: Silvia E. Cestari Candoti. CRBM 1ª Região 27765 Responsible Technician

www.nexfill.com.br

+55 43 3372-5200

BPFBoas Práticasde Fabricação

Dermafill: sterile dressing packed in boxes with 12 units or envelops with 01 unit.

Smooth film sizes:

3 x 4in, 4 x 6in, 6 x 8in.

Porous film sizes:

3 x 4in, 4 x 6in, 6 x 8in.

With pores of 0,03in, 0,05in and 0,09in.

ANVISA Registration 80531090001

Sterilized by gamma radiation.

Advanced Science in Dressings for

the Treatment of Wounds by

Biocellulose

Good Manufacturing Practices

Dermafill is a sterile dressing for the temporary covering of skin lesions, with selective permeability to protect the wound. Interfibrillar spaces in the film offer anchorage points for the fibrin and other blood elements, offering perfect and total adherence to the bloody portion of the lesion. Thus, Dermafill becomes a natural part of the organism as a temporary component, which will fall off with the development of the new epithelial tissue, offering an ideal environment for a complete healing process. Relieves the painPerfect film adherence to the lesioned area isolates nervous terminations,inhibiting painful stimuli. Helps wound healing Dermafill maintains the normal temperature, humidity and oxygenation conditions, preserving the skin natural microenvironment. This facilitates the development of the granulation tissue, guaranteeing the development of new skin of excellent quality.The substantial reduction the number of dressings accelerates the healing process, preventing painful traumas and the risks of infection. 100% natural, made with biocelluloseDermafill has no adhesives that may cause allergic reactions.

Recommendations- Humid wounds with skin loss, with or without bleeding;- Skin grafts donation areas;- Second degree burns;- Chronic ulcers with a tendency to not heal with the use of conventional dressing;- Ulcers and other wounds in diabetic patients. For the treatment of lesions with skin loss, superficial or deep, and with excessive exudation, use Porous Dermafill. Important notice: Both dressings are not recommended for first-degree burns, since the product will not stick to the skin to bring about the expected results. Precautions- Do not use the product when the package has been damaged or violated or the film shows evidence of contamination or damage; - Do not use the product after the expiration date;- Do not reuse the product;- Do not apply the product in case of wound infection.

After total Dermafill adherence (15 to 20 minutes), trim the film edges. When using Porous Dermafill, there is no need for a secondary dressing; however, it can be used to maintain Dermafill on the region of friction or to offer more comfort to the patient who does not want to visualize the wound.

Wash the wound carefully for a perfect cleaning of the lesioned area. Then, remove Dermafill from the package.

Dermafill does not contain adhesives. For a perfect adherence, remove eventual air bubbles by compressing them softly with a moist gauze. It is important to maintain the lesioned area immovable for 15 to 20 minutes.

Place Dermafill on the lesion. The dressing must cover the whole wound, approximately 1 cm beyond the edge. If necessary, use two or more Dermafill films, placing one on top of the other (more or less 1 cm).

When using Porous Dermafill, place a dry, sterilized gauze on the dressing. Fix the gauze with a band, compressive bandages, adhesive tape, micropore tape or similar.

CASE 1

CASE 2

CASE 3

CASE 4

CASE 5

CASE 6

Burns

Second-degree

Burns

Ulcer with

necrosis

Pressure ulcer

in patients

with diabetes

Venous

Ulcers

Vascular ulcer

in patients

with multiple

myeloma

CASE STUDIES

Use and Application: General Instructions

• In case of wounds with excessive bleeding or exudation use Porous Dermafill.• In case of wound infection, remove the dressing immediately and treat it. • Reapply the product only after the infection is cured.