needed. This includes otolaryngology, the peritoneum area, and others
which have a higher blood flow.
WARNING
This product use is restricted to dental surgeons/ doctors
and rescue area professionals.
NOTE
The product is absorbed by the body in a period
between 24 - 48 days.
2. COMPOSITION
- Natural vegetal polysaccharide and carboxymethyl cellulose.
3. ACTION MECHANISM
The polysaccharide, in contact with the blood, absorbs the most fluid
part of it (plasma), forming a gel. In the edges of this gel, the platelets,
red blood cells and other blood components are concentrated, accel-
erating the natural hemostasis process. The carboxymethyl cellulose
helps in the affected are protection, working as a protective film, pre-
venting the adherence formation.
4. DISPLAY FORMATS
See table 1.
5. STORAGE AND TRANSPORTATION
Keep in a place protected from direct light, heat and away from chil-
dren. Store the product in room temperature.
6. STERILE PRODUCT
The product is provided sterile; therefore the package must be sealed
before use. Bleed STP+ Sponge is sterilized with gamma ray.
WARNING
The material cannot be re-sterilized. In case there is material remain
after use, it must be disposed.
7. INSTRUCTIONS OF USE
▪ Open the external package (tertiary) and check if the secondary pack-
age (surgical grade paper) is intact;;
▪ Open the secondary package (surgical grade paper) in the moment of
the operating table preparation;
▪ Open the primary package (blister) only in the moment of the
product application;
▪ The final product shall be used at the maximum 2 hours after blister
opening and shall not be used in another patient or surgery.
Instructions of use for the hemostatic function
Apply the product directly on the area where the bleeding is taking
place and, if necessary, slightly press it with gauze. If the bleeding con-
tinues, remove the product excess, with the help of physiological serum
or water for injection, soaking the product and removing it when a gel
is formed, and repeat the application.
Instructions of use for the non-stick and ant fibrotic function
Apply the product directly on the area where adherences or fibrosis
may occur, without excess, and normally suture the area, since it will
be absorbed by the body.
When used in nasal cavities, remove the product from 3 to 5 days, with
the help of a physiological serum, and if necessary, apply it again.
8. GENERAL SAFETY INSTRUCTIONS
▪ Restrict use by the Dentist Surgeon/Surgeon and rescue area professionals;
▪ This product application must be restricted to the treatment area;
▪ This product must be handled by the operation with protective gloves;
▪ Once the hemostasis is reached, the excess of Bleed STP+ Sponge
of the application area must be removed, irrigating with physiological
serum and aspiring, especially when used in bone foramens, in bone
edges, in the spinal cord, and/or in the nerve and in the optic chiasm.
In the case of product use as a hemostatic, the Bleed STP+ Sponge
which remains after the application must be removed, since the ma-
terial excess removal reduces the chance for the product to interfere
in the regular physiological functions and/or cause necrosis due to the
adjacent tissues compression.
▪ The Bleed STP+ Sponge safety and efficacy were not clinically tested
in children or pregnant women. It was observed that the amylase ac-
tivity is lower in newborns and babies up to the first ten months of life.
Therefore, the Bleed STP+ Sponge must take more than 40 days to be
absorbed in this population.
▪ The Bleed STP+ Sponge must be carefully used in case or infection
or if used in contaminated areas in the body. In case there is a sign of
abscess or infection after application, a new intervention for drainage
may be necessary.
▪ The Bleed STP+ Sponge must not be used to control postpartum
bleeding or menorrhagia.
9. SIDE EFFECTS
There are no reports of collateral effects for this product.
10. CONTRAINDICATIONS
▪ Don't mix this substance with vasoconstrictor substances: epinephrine,
racemic epinephrine, ferric chloride, ferric sulfate, aluminum chloride, etc;
▪ The Bleed STP+ Sponge is not recommended in the primary treatment
of clotting disorders;
▪ Tests with the use of Bleed STP+ Sponge in bone surfaces were not
carried out before the placement of prosthetic materials with adhe-
sives. Therefore, such use is not recommended;
▪ Don't apply more than 100 g of Bleed STP+ Sponge in diabetic pa-
tients, because, according to the calculations, quantities higher than
this may influence the glucose levels.
11. PRECAUTIONS
▪ Use the Bleed STP+ Sponge until the validity date;
▪ The Bleed STP+ Sponge was designed to be used individually, and its
hemostatic efficacy decreases when in contact with saline solutions or
with antibiotics before hemostasis;
▪ In urological procedures, the Bleed STP+ Sponge cannot be left in
the renal pelvis or in the urethras, in order to eliminate possible stone
formation spots.
12. LIMITATIONS
In case this product shall be used in cranial operations, remove the
maximum product possible before the final suture, with the help of
physiological serum and aspiring.
13. VALIDITY
The product has a validity of 2 years from the manufacturing date. After
the surgical grade paper package (primary and secondary), the product
shall be used immediately.
Tabela 1/ Tabla 1/ Table 1
O Bleed STP+ Sponge é comercializado nas seguintes apresentações:
El Bleed STP+ Sponge es comercializado en las siguientes presentaciones:
Bleed STP+ Sponge is sold in the following formats:
Dimensões
Quantidade por caixa
Imagem
Dimensione
Imagen
Dimensions (mm)
Image
A x B x C
50 x 80 x 10
40 x 80 x 10
20 x 80 x 10
25 x 80 x 7
15 x 80 x 7
15 x 80 x 1
A
20 x 80 x 1
B
25 x 80 x 1
40 x 80 x 1
50 x 80 x 1
50 x 70 x 10
C
20 x 60 x 7
20 x 20 x 7
30 x 30 x 10
80 x 125 x 10
100 x 120 x 10
80 x 250 x 10
A
B
10 x 10 x 10
C
Dimensões
Dimensione
Dimensions (mm)
A x B
B
30 x 80
A
5 x 80
Cantidad por caja
Quantity per box
(uni.)
1, 3, 5
ou, o, or 10
