Curiosin

Curiosin

Manufacturer:

Gedeon Richter

Distributor:

PHARMASIA
Full Prescribing Info
Contents
Zinc hyaluronate 0.1%.
Description
Each topical gel contains zinc hyaluronate 15 g.
CURIOSIN is a viscotherapeutic wound care product family available in two forms: Gel and Fluid. Both products are microbiologically clean*, clear, odourless, aqueous and preserved, filled in multidose containers (Gel: 15 g; Fluid: 10 ml). CURIOSIN is composed principally of zinc-hyaluronate, a new, patented complex of highly purified hyaluronan derived from animal sources (rooster's comb).
*Microbiologically clean: The products meet the requirements of Ph.Eur. for the "Microbiological quality of topical preparations".
The main component of CURIOSIN, hyaluronan is an essential constituent of the skin and the connective tissue, responsible for the integrity, elasticity of the skin and the regeneration after trauma. Zn-hyaluronate as a complex of hyaluronan has additional benefits.
Healing may be accompanied by reduced scarring (foetal wounds heal without scarring which is largely attributed to the extremely high hyaluronan content) and hyaluronan helps to restore the compromised skin to its natural condition and appearance.
Excipients/Inactive Ingredients: Gel: carbomera (gel forming agent), potassium sorbate (preservative), water for injections.
Fluid: sorbitol (isotoniser), potassium sorbate (preservative), water for injections.
Action
Pharmacology: Pharmacodynamics: CURIOSIN helps the compromised (damaged, wounded, scratched, burnt, pimpled) skin to heal by primary or secondary intent: managing the microenvironment of the damaged area by water retention and delivery, acting as a mechanical and anti-microbial barrier and forming a biocompatible molecular bandage. This means that it will act as a hydrated bandage and keep the compromised skin moist, which is the primary objective of the treatment of wounds and burns. Once applied the hydrated Zn-hyaluronate layer forms a dense molecular network that acts as an elastoviscous molecular filter and prevents microorganisms from the environment (airborne and contact origin) from reaching the compromised skin surface. In this way, the hydrated hyaluronan layer acts as an anti-microbial bandage. By the same mechanism it also provides a protective shield against tissue damaging factors via scavenging reactive oxygen species resulting in reduced wound pain and tissue inflammation. Owing to some unique feature hyaluronan represents one of the most biologically compatible wound dressings.
Indications/Uses
For over-the-counter use: superficial wounds such as minor traumatic wounds (abrasions, lacerations, cuts), minor burns (first and second degree burns); mild-to-moderate form of acne vulgaris.
Under the supervision of a healthcare professional: chronic wounds such as leg ulcers of different origin and decubitus.
Dosage/Direction for Use
Over-the-counter use: Minor traumatic wounds: Clean the wound surface with saline or water, wait until bleeding stops, and apply CURIOSIN in a thin layer (1mm of the Gel or 1 drop/cm2 of the Fluid) to the entire wound surface. Covering the wound is optional, the patient may let CURIOSIN dry on the surface or may cover the wound with a primary non-stick gauze dressing and a self-adhesive bandage.
CURIOSIN can be used repeatedly.
Minor burns: Cool the burnt surface with running cold water and apply CURIOSIN as instructed previously.
Mild-to-moderate form of acne vulgaris: After cleansing gently rub CURIOSIN into the affected skin area twice daily (rub gently until completely absorbed to avoid dried remnants of the gel on the skin).
Use under the supervision of a healthcare professional: A healthcare professional should be consulted prior to the first use of and for the duration of the treatment with CURIOSIN for chronic wounds. The treatment of chronic wounds like leg ulcers, pressure ulcers, diabetic ulcers should be under the supervision of a healthcare professional who will instruct on the other elements of the complex therapy of the underlying disease (e.g.: compression bandage, pressure relief measures, blood glucose control, infection control); complete debridement if needed), clean the skin area to-be-treated by gently rinsing with saline or water and wait until bleeding stops; apply CURIOSIN as a continuous thin layer (1 mm of the Gel or 1 drop/cm2 of the Fluid) to the entire compromised skin area(s) if necessary, a clean application aid e.g. a cotton swab or a tongue depressor can be used); once CURIOSIN has been applied, you may cover the wound with a non-stick gauze dressing and wrap it over with a self-adhesive bandage; repeat the process of wound cleansing, applying CURIOSIN and bandaging daily, in the case of heavily exuding wounds two times a day.
Special Precautions
CURIOSIN is for topical use only! The patient should not use CURIOSIN if the patient has a known hypersensitivity to any of the ingredients of CURIOSIN or poultry proteins.
CURIOSIN Fluid is not an eye-drop- do not instill into the eyes. In case of accidental swallowing rinse mouth (though it is unlikely that it will do any harm to the patient).
The tip of the tube and the bottle should not come into contact with the wound or any other surface and care should be taken during use to avoid any other forms of possible microbial contamination or spoilage.
Marketed in multidose containers, but the devices are intended for one patient only.
Consult a healthcare professional if: the patient observes non-ceasing irritation, reddening, inflammation, maceration (whitening of the skin), hypergranulation (excess tissue formation) or sensitivity (allergic reaction);
if the wound appears to get larger after the first three or four applications;
signs of infection occur (increased pain, bleeding, wound drainage);
there is a change in wound colour and/or odour;
the wound does not begin to show signs of healing in a few days;
any other unexpected symptoms occur.
Adverse Reactions
In some case local hypersensitivity (allergic reaction) may emerge.
The following symptoms may occasionally occur at the beginning of use: redness, mild transient stinging or burning sensations, and local pain. The following conditions were reported very rarely during clinical trials: hypergranulation and partial necrosis found only in a very limited area of the wound bed, but the causal relationship to CURIOSIN therapy has not been established.
Storage
Store at room temperature. Avoid freezing.
Before first use check seal is intact. Close tightly after each use.
ATC Classification
A12CB03 - zinc protein complex ; Belongs to the class of zinc-containing preparations. Used as dietary supplements.
Presentation/Packing
Topical gel 0.1% (clear, odourless, aqueous) x 15 g x 1's.
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