Mediclore

Mediclore

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Polymeric gel.
Description
MEDICLORE Bioresorbable Adhesion Barrier is a sterile, single use, polymeric gel. The gel is absorbable combination of sol-gel transition temperature-controllable polymer and chitosan which is non-pyrogenic and highly biocompatible. It is intended to be placed at surgical site and serve as a temporary, absorbable mechanical barrier separating opposing tissue surfaces during the course of normal healing.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: MEDICLORE is believed to perform its function through a physical effect by providing a temporary separation of surfaces by providing a lubricative surface coating with gelation of sol-gel transition behavior in-vivo. This minimizes tissue apposition during the critical period of fibrin formation and mesothelial regeneration following surgery, thereby providing a barrier to adhesion formation.
Indications/Uses
MEDICLORE is indicated for use as an adjunct to good surgical technique in both open and laparoscopic procedures (e.g. General, Gyn., Spine, ENT and Orthopaedic surgery) for reducing the incidence, the extent and the severity of post-operative adhesions at the surgical site.
Dosage/Direction for Use
Preparation and Application: Aseptic technique should be maintained to minimize the potential risks of post-operative complications: At the conclusion of surgery, and prior to closure, remove all irrigation fluid and achieve hemostasis and remove hemostatic materials.
With hemostasis achieved, apply MEDICLORE to coat the surgical surfaces.
Remove the outer and inner package and introduce the syringe and the catheter to the sterile field.
Check the inner package if any defect presents prior to use.
Take the syringe from the inner package, remove the twist-off rubber cap and connect to the catheter. If the spray is used instead, connect to the spray nozzle.
Push the syringe piston slowly and apply carefully to the surgical site to be fully coated.
Dispose of the remaining solution (gel), syringe and catheter.
Contraindications
MEDICLORE is contraindicated in patients with known or suspected allergy to components of the device and in the presence of infection.
Warnings
Do not inject MEDICLORE into blood vessels or allow it to enter blood vessels.
Special Precautions
MEDICLORE is NOT for intravenous (IV) administration.
MEDICLORE is not indicated as a delivery system for intraperitoneal drugs such as antibiotics and chemotherapeutic agents.
As with other surgically implanted foreign material, MEDICLORE should not be used where contamination or infection of the operative field is suspected.
Do not use if pouch is damaged or opened prior to use.
Single use only.
Do not re-sterilize.
Adverse Reactions
Infection; Allergic reactions; Pain; Inflammation.
Storage
Room temperature (15~30°C), The product does not require refrigeration but should never be exposed to temperatures greater than 39°C.
Shelf-life: 2 years from the date of manufacture.
ATC Classification
V20 - SURGICAL DRESSINGS ; Used as surgical dressings.
Presentation/Packing
Gel (pre-filled syringe) 1 mL x 1's, 1.5 mL x 1's, 3 mL x 1's, 5 mL x 1's.
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