niños o en mujeres embarazadas. Se observó que la actividad de análisis es
más baja en recién nacidos y bebes hasta los primeros diez meses de vida;
por lo tanto, el Bleed STP+ puede llevar más de 28-40 días para ser absorbido
en estas personas;
▪ El Bleed STP+ debe ser usado con cuidado si hay infección o es utilizado en
ares contaminadas del cuerpo. Si existe alguna señal de absceso o infección
después de la aplicación del Bleed STP+, puede ser necesaria una nueva inter-
vención para drenaje;
▪ La seguridad y eficacia en procedimientos oftalmológicos no fueron establecidas.
▪ El Bleed STP+ no debe ser usado para controlar hemorragia post parto o menorragia.
9. EFECTOS COLATERALES
No hay relatos de efectos colaterales de este producto.
10. CONTRAINDICACIONES
▪ No mezclar esta sustancia con vasoconstrictores: epinepherína, epinefrina
racémica, cloratos de hierro, sulfato férrico, clorato de aluminio, etc;
▪ No inyecte, ni use el Bleed STP+ en vasos sanguíneos, pues puede ocurrir emboli-
zacion u óbito;
▪ El Bleed STP+ no está recomendado en el tratamiento primario de disturbios
de coagulación;
▪ No fueron realizados test con el uso de Bleed STP+ en superficies óseas antes
de la colocación de materiales protéticos con adhesivos; por lo tanto, tal utili-
zación no es recomendada;
▪ No aplique mas de 50 g de Bleed STP+ en pacientes diabéticos, pues, según los
cálculos, cantidades superiores a esta pueden influencias los niveles de glicosis.
11. CUIDADOS
▪ Utilizar el Bleed STP+ hasta la fecha de validad;
▪ Después de la ruptura del embalaje del papel grado quirúrgico (embalaje
estéril), utilizar el Bleed STP+ inmediatamente;
▪ El Bleed STP+ fue proyectado para ser utilizado en estado sólido, y su eficacia
hemostática disminuye cuando está en contacto con soluciones salinas o con
antibióticos antes de la hemostasia;
▪ En procedimientos urológicos, no se debe dejar el Bleed STP+ en la pelvis
renal o en los uréteres, a fin de eliminar posibles focos de formación de cálculos.
12. VALIDAD
El producto posee validad de 2 años a partir de la fecha de fabricación. Después
de la abertura del embalaje papel grado quirúrgico (terciario y secundario), el
mismo deberá ser usado inmediatamente.
ENGLISH
1. BLEED STP+ COMPOSITION
Natural vegetable polysaccharide and carboxymethylcellulose (CMC).
2. FUNCTION AND INDICATION
The Bleed STP+ should be used in procedures where the acceleration process
of the natural hemostasis of blood is required. The product is indicated for
surgical and curative procedures external to the body.
There is no scientific study regarding the use of the product in the ophthal-
mologic area.
WARNING
This product is of restricted use to the surgeons dentists/doctors and pro-
fessionals of the rescue area.
OBSERVATION
The product is absorbed by the organism in a period
between 28 - 40 days.
3. ACTION MECHANISM
The formulation of the Bleed STP+ 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 insulating film.
4. PRESENTATION FORMS
Bleed STP+ is commercialized in the following Kits:
▪ Kit 1:
- 1 applicator (wind type)
with 1 or 3 or 5 g;
- 1 cannula;
- 1 User Manual.
▪ Kit 2:
- 3 applicators (wind type - as picture
aside) with 1 or 3 or 5 g each;
- 3 cannulas;
- 1 User Manual.
5. STORAGE AND TRANSPORT
Keep in place protected of direct light, heat and far from the children reach.
Store the product in ambient temperature.
6. STERILE PRODUCT
The product is supplied sterile, therefore the packing must be sealed up before
the use. Bleed STP+ is sterilized with gamma ray.
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 the external packing (quaternary) and verify if the tertiary (blister)and
secondary packings (surgical degree paper) are unbroken;
▪ Open the tertiary packing (blister) at the moment of the surgical table preparation;
▪ Open the secondary packing (surgical degree paper) only at the moment of
the product application;
▪ For nasal surgery and laparoscopy, attach the cannula to the bellows-type
applicator, as pictures below:
Remove the applicator tip by unscrewing it in a counterclockwise direction.
Screw the cannula in the applicator tip, screwing it in clockwise direction.
Hemostatic Function
▪ Apply the product directly on the place that occurs the bleed and pressure it
lightly with a gauze (as pictures below).
▪ After 30 seconds, remove the gauze and verify if the bleed was interrupted. If
the bleed persists, remove the product excess and repeat the application. Use
water or serum to humidify the gauze at the moment of removing it.
Control of Adhesion Formation
▪ At the end of surgery, apply a thin film of product directly on the site where
will occur possible adhesion formation. PRODUCT SHALL NOT BE REMOVED.
▪ Finish the surgical procedures as needed.
8. SECURITY GENERAL INSTRUCTIONS
▪ Restricted use of the professional Dentist Surgeon /Surgeon and professionals
of the rescue area;
▪ The application of this hemostatic must be restricted to the treatment area;
▪ This product must be manipulated by the operator with protection gloves;
▪ Once the hemostasy is gotten, the excess of Bleed STP+ must be removed
from the application place irrigating and inhaling, mainly when used in osseous
foramen, regions of osseous confines, the spinal marrow, and/or the nerve and
optic chiasmus. The product increases its volume when in contact with liquids.
The dry and white Bleed STP+ that remains after the application must be remo-
ved, therefore the removal of the dry excess material reduces the possibilities
of the product to intervene in the normal physiological functions and/or to
cause necrosis for compression of adjacent tissues;
▪ The security and the effectiveness of Bleed STP+ had not been tested clini-
cally in children or in pregnant women. It was observed that the amylase activi-
ty is lower in babies born and babies until the first ten months of life; therefore,
Bleed STP+ can take more than 28-40 days to be absorbed in this population;
▪ Bleed STP+ must be used with care if there is infection or if used in contami-
nated areas of the body. If there is any signal of abscess or infection after the
application of Bleed STP+, a new intervention for draining can be necessary;
▪ The security and effectiveness in ophtalmologic procedures had not been established;
▪ Bleed STP+ must not be used to control hemorrhage after-childbirth or menorrhagy.
9. COLLATERAL EFFECT
There aren't stories about collateral effect of this product.
10. COUNTERINDICATION
▪ Do not mix this substance with vase-constritors: epinepherine, racemic epine-
frine, iron chlorides, ferric sulphate, aluminum chloride, etc;
▪ Do not inject, nor use Bleed STP+ in sanguineous vases, therefore it can occur
embolization or death;
▪ Bleed STP+ is not recommended in the primary treatment of coagulation riots;
▪ Tests with the use of Bleed STP+ in osseous surfaces before the rank of pros-
thetic materials with adhesives had not been carried through; therefore, such
use is not recommended;
▪ Do not apply more than 50 g of Bleed STP+ in diabetic patients, therefore, accor-
ding to calculations, superior amounts than this can influence the glucose levels.
11. CARES
▪ Use Bleed STP+ until the validity date;
▪ After the rupture of the surgical degree paper packing (barren packing), use
Bleed STP+ immediately;
▪ Bleed STP+ was projected to be used in the solid state, and its hemostatic
effectiveness diminishes when in contact with saline solutions or antibiotics
before the hemostasy;
▪ In urologic procedures, must not leave Bleed STP+ in renal pelvis or ureter, in
order to eliminate possible focus of calculus formation.
12. VALIDITY
The product possesses validity of 2 years from the manufacture date. After
the opening of the surgical degree paper packing (tertiary and secondary), the
same must be used immediately.
