HYPEROIL
FAQ

Shelf life of all marketed formulas is 4 years, assuming they are unopened and properly stored (shelf life test). Period After Opening (PAO): Oil formulation: 24 month (24M) Gel: 12 months (12M)

In the gel the active principles are more diluted, whilst in the oil formulation they are more concentrated.

Definition of Hyperoil® active ingredients: component’s synergic action. The two plants, Neem and Hypericum Perforatum, have more than hundred constituents each. Due to the huge number of possible combinations among the two plants constituents, the law applicable for Medical Devices bearing CE Certification under class IIb, exempts to demonstrate which component is responsible of the product effectiveness. The components identified as present in major quantity are Hyperforin (from Hypericum Perforatum) and Azadirachtin (from Neem), considered presumably the two most important “Active Ingredients”. Percentages of these two components are monitored for each finished product lot; said percentages must be kept within specific range (ppm) of the Device used during clinical trials showing effectiveness without recording any side effects. It is well known that, together with such primary constituents, there are more than 300 phytochemicals which are part of Hyperoil®; some of them are present in such small quantities that no analytical method have been yet developed to detect them. The coadjuvant action of Hyperoil® in wound healing cannot be attributable solely to the predominant constituents (Azadiracthin and Hyperphorin) but to the synergic action of all constituents. Based on a reasonable concept of proportional content of components, the monitoring of predominant components, Hyperphorin and Azadirachtin, allows indirect control of formulation constituents, participating in a synergy to the performance of the Medical Device. CE Certification has been obtained by demonstrating effectiveness of clinical trials, suitability through risk analysis and reliability through laboratory tests required for Medical Devices.

A DETAILED BASE PROTOCOL FOR USE ON HYPEROIL® IS AVAILABLE. INFLAMMATION PHASE: in case of necrotic tissue or fibrin, it is recommended to use the oil formulation with non-woven gauzes. The dressing can be changed daily and previously washed with saline solution at each change. GRANULATION PHASE: apply gel spray or cream + gauze with gel + non-woven gauzes. REEPITHELIALIZATION PHASE: use gauzes with gel + non-woven gauzes or absorbent dressing.

Because this type of anti-inflammatory causes the healing process to stop, torpid sores, bacterial and fungal superinfections.

The rule is: - on lesions with low or a moderate degree of secretion → TNT GAUZES - on lesions with a great deal of secretion → absorbent CUSHIONS or COMPRESSES It is recomended the use of: - Sterile hydrophilic TNT GAUZES - ABSORBENT COMPRESSES - ABSORBENT CUSHIONS - COHESIVE ELASTIC CREPE BANDAGES

- Just like other advanced wound dressings, Hyperoil® is not effective on necrotic tissue if tissue hypoxia is less than 30mmHg of O2 (Mercuric Oxyde) - A temporary burning sensation could arise (especially with the oil solution) but then it will gradually decrease. - Bleeding in a lesion is a very positive sign as it means that a chronic lesion is in the process of returning to an acute lesion. - At temperatures below 17°C, the oil formulation tends to solidify but on application to the skin, spreads easily and immediately. The properties remain unchanged. - The product is air and light sensitive. Air exposure must be linked to the usage period. The product must be properly sealed after the use. Keep the product in a cool and dry place.

FAST ACTING EASY TO USE EFFICACIOUS COST EFFECTIVE VEGETAL MULTI-FUNCTIONAL SELF-SUFFICIENT ADVANCED WOUND DRESSING

For every wound, anytime