HEMA LIMIT
Matrix & Powder
OXIDISED-CELLULOSE BASED HAEMOSTATS
HEMA LIMIT
Matrix
OXIDISED-CELLULOSE BASED HAEMOSTATS
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
HEMA LIMIT matrix is a sterile haemostatic
preparation based on oxidised cellulose available in flat
form with textile structure.
Content: Carboxycellulosum 100%
(oxidized cellulose)
Sterile
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
What is it used for
Excellent haemostatic agent to professionally arrest
capillary bleeding, or bleeding from parenchymatous organs
and resection areas at surgical procedures.
It shall be used to stop bleeding when other haemostatic
procedures are not applicable.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
How is it made
HEMA LIMIT is produced by selective oxidation of high-quality cotton
material (99% of cellulose content at minimum).
The process selectivity lies in the fact that predominantly alcoholic
group on 6th carbon of basic building unit is oxidized and carboxyl is
formed (- COOH), whose content is maintained at 16 – 24 volume
percentage according to USP.
From the chemical point of view it is polyanhydroglucuronic acid (used
for HEMA LIMIT matrix), whose acidity is decreased by neutralization
to calcium salt (used for HEMA LIMIT powder form).
As free carboxyl group is a carrier of oxidized cellulose bactericidal
effect, only a part of those groups is calcium bound, residual ones are
free.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
How does it work
HEMA LIMIT has a significant effect on starting the
haemocoagulation process, and accelerates the blood coagulation
in several ways.
While applied, Factor VII is activated as well as the thrombocyte
activation is initiated by tissue factor. Due to anion active
characteristics of oxidized cellulose, HEMA LIMIT is able to form
complex polymers with compounds such as fibrinogen or
haemoglobin, therefore fibrinogen polymerization is speeded up.
Calcium ions (powder form) are used during protein complex
fixation on cell membranes, in particular thrombocytes and endotel
cells. Higher Ca2+ ion concentration stabilizes activated Factor V
and speeds up
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
How does it work
Factor XIII activity resulting in fibrinogen network stabilization
which is therefore able to create sufficiently organized structure for
fibroblast growth and cicatrix formation.
During coagulation process Ca2+ ions partially participate in
thrombocyte adhesion to collagens of exposed wound, and also
show partial analgesic effect. This is considered to be due to ion
blockage effect on autonomous nerve-endings.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Special Characteristics (Features)
Its indisputable advantage is the possibility of fixing the
material by stitching.
Due to the content of carboxyl groups (16-24%) that have the
proven features of being bactericidal and bacteriostatic, and
further due to the increased fibroblast activation initiated by
the active substance, the healing process in the application
area is more rapid.
Therefore, HEMA LIMIT matrix shall be used for faster healing
of non-responding wounds such as lacerations, leg ulcers,
decubitus, bed sores etc.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application/Clinical
Experience
It is suitable for use in:
* general surgery and digestive surgery,
* plastic surgery,
* orthopaedic surgery,
* neurosurgery,
* thoracic surgery,
* vascular surgery,
* gynaecology,
* urology
and all other branches of surgery, traumatology and
stomatology.
In dental praxis, the preparation shall be also used to arrest
prolonged post-extraction capillary bleeding.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application
Neurosurgery
Haemostasis (epidural) after tumor extirpation. Cerebral
parenchyma haemostasis.
Application:
* Bleeding from cranium vault at craniotomy and Dura mater
rupture
* Bleeding from spongy layer, e.g. after trephination
* Cranial Dural haemorrhage
* Dural bleeding after tumor extirpation
* Cerebral parenchyma bleeding
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application
Thoracic/vascular surgery
Bleeding / madescent prophylacy caused by suture canals after
anastomosis. Relief at haemostasis of wounded or resected
parenchyma.
Application:
* Bleeding which might occur during surgical procedures with
extracorporeal circulation
* At pericardectomy after removing pericardium and pleura
adhesion
* Bleeding from suture canals, i.e. after vascular anastomosis
* At thoracic wall surgery
* Bleeding from pulmonary parenchyma after wound or resection
treatment of bleeding from tumor matrix
* Epicardium bleeding
* After breaking adhesion round heart
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application
Plastic Surgery
Support at graft fixing, stopping madescent of donator graft
removal spots. Stopping madescent and support of granular
tissue healing.
Application:
* Cosmetic surgery
* Complicated reconstructions at:
• Palate reconstruction
• Post traumatic skin reactions
• Burns
• Bleeding from donator graft
• Removal spots
* Bleeding from spongy tissue
* Bleeding from oral cavity mucous membrane after tumor
resection
* Bleeding from spongy tissue
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application
Soft Tissue Surgery
Haemostasis of gall bladder matrix after holecystectomy.
Supporting preparation for shopping madescent after
liver/spleen lesion. After biopsy as well.
Application:
* On lesions in liver after resections and cholecystectomies
* Supporting preparation at liver rupture
* Liver biopsy
* Rectal surgery
* After breaking adhesion Spleen capsule ruptures Thyroid
gland surgery
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application
Gynaecology
Applied at hysterectomies.
Haemostasis after removing cervical carcinoma.
Application:
* Bleeding at surgery on uterus and cervix (conisation),
breaking adhesion in lesser pelvis and Douglas area
* Tumor bleeding treatment at hysterectomies
* After removing cervical carcinoma
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application
Urology
Stopping difficult bleeding/madescent after prostatectomy.
Parenchyma haemostasis.
Application:
*
*
*
*
Tumor bleeding treatment
At hysterectomy
After removing cervical carcinoma
After removing fibroids
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application
Stomatology
Application:
* At treating postextraction wounds.
* Haemostasis at maxillofacial surgeries.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Dosage/Method of Use
After opening the outer/secondary packaging, take out the
inner/primary packaging.
This primary packaging is sterile and contains the chosen
preparation of HEMA LIMIT matrix.
The preparation could be adjusted / cut by sterile instruments
to the requested application size and then it could be applied
onto the bleeding area.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Dosage/Method of Use
The material saturated with blood forms a brownish layer that
shall not be removed - it will be fully absorbed.
The haemostatic effect is immediate; the full haemostasis is
achieved within 2 minutes.
Another layer could be applied in case the blood still oozes
through.
The material could be stitched to the tissue if recommended
by surgeon.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Packaging
The material is packed into double sterile packaging.
The primary/inner packaging is a silver/black foil having a
peel-effect on one side to enable an easy opening.
The secondary/outer packaging shall be one-side transparent,
with a peel-effect on one side for an easy opening.
Sterility
Sterilized by gamma irradiation
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Storage Conditions
Store in a dry room at room temperature (preferably
between 5-25oC).
For a long-term storage we recommend to store the
material below 20oC .
Do not expose to direct light.
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
Dimensions
Individual pieces of active textile matrix are always with a
given width that remains unchanged whereas its length could
be adjusted according to specific demands of customers.
Dimensions Provided
50 x 50 mm
50 x 70 mm
50 x 100 mm
50 x 350 mm
100 x 100 mm
100 x 200 mm
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
HEMA LIMIT matrix in brief
• is destined to arrest capillary and minor venous bleeding and bleeding from
parenchymatous organs and resection areas, at any kind of surgical interventions
• could be applied into cavities (after extirpation of tumours) as well dental praxis
• the haemostatic effect is almost immediate, the full haemostasis is achieved by 2
minutes after application
• is fully absorbed by 12 - 72 hours, depending on the application form and wound
extent
• is entirely eliminated from the body within 7 - 21 days, leaving no deposit
behind in tissues and cells
• is biocompatible, biodegradable, non-acidifying haemostatic preparation of natural
origin
HEMA LIMIT matrix
OXIDISED-CELLULOSE BASED HAEMOSTAT
HEMA LIMIT matrix in brief
• is hypoallergenic - no sensitive features have been reported, no immune-reactions
have been initiated, even after repeated application
• is well tolerated by the organism and has a significant effect on healing process in
wounds
• causes no irritating reactions on the application area, no granuloms are formed
• has bactericidal and bacteriostatic features due to the presence of carboxyl
groups
• no adverse effects as such have been reported
• is an ideal alternative to bovine fibrins and collagens
HEMA LIMIT
Powder
OXIDISED-CELLULOSE BASED HAEMOSTATS
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
HEMA LIMIT powder is a haemostatic preparation in a STERILE
powder form, with the active substance based on oxidised
cellulose and is destined to arrest capillary and minor venous
bleeding and bleeding from parenchymatous organs at surgical
interventions.
Content: Calcium hydrogencarboxycellulosum
(hydrogencalcium salt of oxidised cellulose) 100 %
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
Special Characteristics
Due to the content of carboxyl groups (16-24%) and calcium
ions, it supports the biological healing process, and has the
proven features of being bactericidal and bacteriostatic.
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
Areas of Application/Clinical
Experience
It is suitable for use in:
* general surgery and digestive surgery,
* plastic surgery,
* orthopaedic surgery,
* neurosurgery,
* thoracic surgery,
* vascular surgery,
* gynaecology,
* urology
and all other branches of surgery, traumatology and
stomatology.
In dental praxis, the preparation shall be also used to arrest
prolonged post-extraction capillary bleeding.
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
Dosage/Method of Use
After opening the outer packaging and undoing the cover apply
a thin layer of powder on to a bleeding area by repeatedly
pressing the sides of the bottle.
The powder that does not get saturated with blood, is
recommended to be removed. The powder layer saturated with
blood becomes red to dark brown that need not be removed - it
will be gradually absorbed.
In case of an application into a cavity or small area, use the
applicator by fixing it on to the sprinkler.
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
Dosage/Method of Use
If the blood still oozes slightly through, but the powder is not
washed off, apply another layer, or if possible press the layer
down by sterile devices until the haemostasis is initiated.
If needed for a superficial treatment, use a cushion plaster or
dressing.
If the powder is washed off by blood, it indicates an
inappropriate use as the preparation is destined to control nonpressure bleeding only.
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
Packaging
HEMA LIMIT powder is packed into a triple sterile packaging
that guarantees a perfect sterility.
The primary/inner packaging shall be a plastic bottle with a
sprinkler and a cover, with the added applicator for use to
cavities or precise application.
The secondary/outer packaging shall be one-side transparent,
with the peel-effect for an easy opening and the additional outer
packaging shall be one-side transparent, with the peel-effect for
an easy opening.
The packaging contains 3g or 5g of active substance
(according to customers requirements).
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
Packaging Provided
• Hemalimit powder 3grams
• Hemalimit powder 5grams
Sterility
Sterilized by gamma irradiation
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
Storage Conditions
Store in a dry room at room temperature
(preferably between 5-25oC).
For a long-term storage we recommend to store the material below
20oC.
Do not expose to direct light.
HEMA LIMIT Powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
HEMA LIMIT Powder in brief
• efficacious haemostat based on hydrogen calcium salt of oxidised cellulose
• exhibits immediate haemostatic effect, the full haemostasis is achieved within 2-3
minutes after application
• it is destined to arrest capillary and minor venous bleeding and bleeding from
parenchymatous organs and resection areas at any kind of surgical interventions in
ambulances and clinical praxis . It could be applied into cavities (after extirpation of tumours)
as well as during endoscopy interventions or dental praxis.
• fully absorbed in 12 - 72 hours depending on the type of form applied and wound
extent
• entirely eliminated in 7 - 21 days, there are no deposits left behind in tissues and cells
HEMA LIMIT powder
OXIDISED-CELLULOSE BASED HAEMOSTAT
HEMA LIMIT powder in brief
• hypoallergenic - it exhibits no sensitising properties and causes no adverse
immunoreaction of organism even in case of recurrent application
• bio-compatible, bio-degradable, non-acidifying haemostat of natural origin
• well tolerated by the organism and it encourages wound healing where applied
• presents no risk of irritating the wound, no granulomas are formed
• has a bacteriostatic and bactericidal effect, the epithelisation process is
accelerated