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9. EFECTOS COLATERALES
No existen relatos de efectos colaterales de este producto.
10. CONTRAINDICACIONES
▪ No mezclar esta substancia con vasoconstrictores: epinefrina, epinefri-
na racémica, cloruros de hierro, sulfato férrico, cloruro de aluminio, etc.;
▪ No inyectar, ni usar Bleed STP+ Gel en vasos sanguíneos, puesto que
puede provocar embolización u óbito;
▪ Bleed STP+ Gel no es recomendado para el tratamiento primario de
disturbios de coagulación;
▪ No se realizaron pruebas con el uso de Bleed STP+ Gel en superficies
óseas antes de la colocación de materiales protéticos con adhesivos; por
lo tanto, tal uso no es recomendado;
▪ No aplicar más de 100 g de Bleed STP+ Gel en pacientes diabéticos,
puesto que, según los cálculos, cantidades superiores a esta pueden
influenciar los niveles de glucosa.
11. CUIDADOS
▪ Utilizar Bleed STP+ Gel antes de la fecha de caducidad;
▪ Bleed STP+ Gel fue proyectado para ser utilizado en el estado gel, y su
eficacia hemostática disminuye cuando entra en contacto con soluciones
salinas o con antibióticos;
▪ En procedimientos urológicos, Bleed STP+ Gel no debe ser dejado en la
pelvis renal o en los uréteres, con el propósito de eliminar posibles focos
de formación de cálculos.
12. LIMITACIONES
Si se tiene que utilizar este producto en operaciones craneales, retirar lo
máximo posible del producto antes de la sutura final.
12. VALIDADE
El producto caduca en 2 años desde la fecha de fabricación. Una vez
abierto el embalaje de papel grado quirúrgico (terciario y secundario),
se deberá utilizar inmediatamente.
ENGLISH
1. FUNCTION AND INDICATION
The Bleed STP+ Gel should be used in procedures where the acceleration
process of the natural hemostasis of blood is required. The product is indi-
cated for surgical and curative procedures external to the body.
WARNING
This product is of restricted use to the surgeons dentists/doctors and
professionals of the rescue area.
OBSERVATION
The product is absorbed by the organism in a period
between 24 - 48 days.
2. COMPOSITION
Natural plant polysaccharide, carboxymethylcellulose and water for
injectables.
3. ACTION MECHANISM
The formulation of the Bleed STP+ Gel product was especially designed
for its use in procedures where the control of hemostasis is required.
When in contact with blood, the vegetable polysaccharide absorbs the
most fluid part of this (plasma) to form a gel. The extremities of this
gel concentrate platelets, red blood cells and other blood constituents,
accelerating the natural process of hemostasis.
As a beneficial side effect, the carboxymethylcellulose present in the
formulation helps protect the affected region, acting as a protective in-
sulating film.
4. PRESENTATION FORMS
Bleed STP+ Gel is sold in the following Kits:
▪ Kit with 3 g:
- 1 Applicator (syringe type) with 0.50 g of Bleed STP+ Gel (powder phase);
- 1 Applicator (syringe type) with 2.50 g of Bleed STP+ Gel (liquid phase);
- 1 Syringe adaptor;
- 1 Cannula;
- 1 User manual.
▪ Kit with 9 g:
- 3 Applicators (syringe type) with 0.50 g of Bleed STP+ Gel
(powder phase) each;
- 3 Applicators (syringe type) with 2.50 g of Bleed STP+ Gel
(liquid phase) each;
- 3 Syringes adaptor;
- 3 Cannulas;
- 1 User manual.
5. STORAGE AND TRANSPORT
Keep away from direct light and heat, and away from the reach of chil-
dren. Store product at room temperature.
6. STERILE PRODUCT
The product is supplied sterile, therefore packs should be sealed before
use. Bleed STP+ Gel is sterilized with gamma rays.
WARNING
The material cannot be re-sterilized. In case that it has material
surplus after the use, this will have to be discarded.
7. USE INSTRUCTIONS
▪ Open outer packaging (quaternary) and check whether tertiary (blis-
ter) is intact;
▪ Open tertiary packaging (blister) when preparing surgical table;
▪ Open secondary packaging (surgical grade paper) only at time of prod-
uct application;
▪ Remove powder-phase and liquid-phase syringes covers;
▪ Couple the two syringes with the aid of the syringe adaptor (as shown
below);
▪ Start the to-and-fro system, start by adding all the liquid to the powder.
This movement should be repeated 20 times;
▪ The final product, that is, the combination of powder and liquid phases
should be used within a maximum of two hours after mixing, and it
should not be used on another patient or surgery.
Hemostasis function use instructions
Apply product directly on the site where bleeding occurs, takes place
and, if necessary, apply slight pressure with a gauze. If bleeding per-
sists, remove excess of product and repeat application.
After 30 seconds, in case gauze is used, wet it either with water for
injectables or a physiological saline solution and removing it, observe
whether bleeding has stopped.
Instructions for use of the antiadhesion/antifibrotic function
Apply product directly on the site of possible adherence and fibrosis,
without excesses, and suture the area normally.
8. GENERAL SAFETY INSTRUCTIONS
▪ Use is restricted to Dental Surgeons/ Surgeons and rescue professionals;
▪ Product application should be restricted to the treatment area;
▪ This product should be handled by an operator wearing protective gloves;
▪ Once hemostasis is obtained, the excess of Bleed STP+ Gel should be
removed from the application site by irrigation and aspiration, especially
when used in bone foramens, bone regions, spinal cord and/or in the
nerve or optic chiasm. Product increases in volume when in contact with
liquids. In case product is used as a hemostatic agent, the Bleed STP+ Gel
remaining after the application should be removed of dry material in ex-
cess reduces the chances of product interfering with normal physiological
functions and/or causing necrosis by the compression of adjacent tissues.
▪The safety and efficacy of Bleed STP+ Gel were not clinically tested on
children or pregnant women. It has been observed that amylase activity
is much lower in newborns and babies up to the first ten months of life;
therefore, Bleed STP+ Gel may take more than 40 days to be absorbed
in such population;
▪ Bleed STP+ Gel should be used with caution in the case of infections, or
if used in contaminated areas of the body. In case of any sign of abscess
or infection after product application, a new drainage intervention may
become necessary;
▪ Bleed STP+ Gel should not be used to control postpartum hemorrhage
or menorrhagia.
9. SIDE EFFECTS
There are no side effects reports for this product.
10. CONTRAINDICATIONS
▪ Do not mix this substance with vasoconstrictors: epinephrine, racemic
epinephrine, iron chlorides, ferrous sulfate, aluminum chloride, etc;
▪ Do not inject or use Bleed STP+ Gel in blood vessels as embolization
or death may occur;
▪ Bleed STP+ Gel is not recommended as the primary treatment of co-
agulation disorders;
▪ Tests were not conducted by using Bleed STP+ Gel on bone surfaces
before prosthetic materials placement with adhesives; therefore, such
use is not recommended;
▪ Do not apply more than 100 g of Bleed STP+ Gel on diabetic patients
as, according to calculations, quantities greater than this may influence
glucose levels.
11. PRECAUTIONS
▪ Use Bleed STP+ Gel until the expiry date;
▪ Bleed STP+ Gel was designed to be used in the gel state, and its
hemostatic efficacy is reduced when in contact with saline solutions or
antibiotics;
▪ Bleed STP+ Gel should not be left in the renal pelvis or in ureters in
urological procedures, in order to eliminate possible kidney stone for-
mation focuses.
12. LIMITATIONS
In case this product is used in cranial operations, remove as much of the
product as possible before final suture.
13. EXPIRY
This product is valid for 2 years from date of manufacture. After opening
the surgical grade paper packaging (tertiary and secondary), it must be
used immediately.
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