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FDA Drug Import News

Import Rules Regarding Personal Medicine Orders:

Current FDA policy is not a law or a regulation, but serves as guidance for FDA personnel.

The importation of certain unapproved prescription medications for personal use may be allowed in some circumstances where these factors apply:


    1). The Drug is for personal use and is a 3-month supply or less and not for resale or commercialization.

    2). If no drug commercialization or drug promotion to U.S. residents by pharmacy companies involved in the distribution of the necessary drug exists.

    3). If an individual seeking to import the drug affirms in writing, that it is for the patient's private use and provides the name and address of the licensed American physician responsible for treatment.

    4). Provides evidence that the drug is for continuation of a treatment begun in a foreign country.

    5). The intended use is for a serious condition for which effective treatment may not be available domestically.

    6). If the product is not considered to represent an unreasonable health issue.

    7). Overnite FedEx shipments require copy of your identification and the prescription.

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REVANESSE LIPS
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Sale Price: $325.00
Compared at: $490.00
You Save: $165.00
Product ID : revanesse_lips
Manufacturer: PROLLENIUM MEDICAL TECHNOLOGY
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Description

 


Revanesse® Lips

The unique and delicate properties of the lips require a specially formulated filler to ensure good post-injection results. Revanesse® Lips has been specifically engineered for lip augmentation and definition. The result of this special design is a filler which is easy to inject and mold after injection with fewer incidences of swelling

ADVANTAGES

The Revanesse® line of fillers employs our Thixofix Technology - one of the most advanced methods of cross-linking available- thereby ensuring long lasting results. This patented process also ensures that the products remain easy to inject while not sacrificing viscosity. Additionally, Revanesse® fillers exclusively use HA with a high molecular weight to achieve maximum durability and longevity. In ReDexis® the use of dextranomer beads further enhances the longevity of the product. Overall, this innovative engineering makes the Revanesse® product line unique and exceptionally durable.

 

Thixofix Technology

Because there are many HA based fillers on the market, one may ask, "What makes the Revanesse® product line different?" The answer lies in our unique formula and patented Thixotropic cross-linking technology, which allows a highly viscous gel to be injected easily through a fine gauge needle without causing degradation to the modified HA particles while returning to its viscous state providing a soft smooth feel to the skin once it is injected.

Prollenium's® precisely crafted cross-linking process is designed to maximize the effectiveness of the cross-linked HA chains present in the gel. Links between different HA polymer chains are promoted, while ineffective 'dangling' links and less effective links between portions of the same chain are minimized. This leads to a gel, which derives maximum benefit in terms of mechanical properties and durability, with a minimum amount of BDDE – thus leading to fewer incidences of post injection complications such as swelling.

The osmolality and pH of the gel is balanced to be compatible with the fluid in the skin, neither drawing in or releasing water. This minimizes problems of overfilling or the need for volume correction. As the filler is slowly degraded over time the cross-linked network is loosened and this allows for slow expansion of the gel particles that partly offsets the natural loss in dermal filler volume, maintaining the level of correction.

Optimizing all these properties provides for a dermal filler with superior performance and patient satisfaction.

MONOPHASIC:

 

HA dermal fillers typically fall into one of two categories: biphasic or monophasic. Biphasic HA products consist of particles of stabilized HA gel suspended in a non-stabilized HA fluid. In contrast, monophasic HA products, such as Revanesse®, are made entirely of stabilized, non-particle, HA gel. The benefit of this approach is two fold.

First, the body's breakdown of biphasic HA differs from that of monophasic HA. Biphasic HA experiences a rapid initial degradation of the non-stabilized HA carrier fluid and a slower degradation of the stabilized HA gel; to combat this effect the physician will over-correct to compensate for the initial rapid degradation. This can lead to less than satisfactory results.

In contrast, monophasic HA degrades in a simple, consistent manner, allowing the physician to correct to the desired look thereby taking the guess work out of the final outcome. Second, in monophasic fillers, the entire volume of the syringe is filled with fine, soft gel particles packed together. This uniform composition leads to the desirable qualities of smoothness, uniformity, and accurate filling

EASE OF USE

The greatest care has been taken to ensure that the Revanesse® line of fillers is easy to inject. We have designed our syringes to include extra wide finger flanges and broadened pistons that provide much greater ease of use. This new design allows the physician a much higher degree of flexibility when injecting. The strong shear-thinning behavior of our HA formulation enables even the highly viscous Revanesse® Ultra to be easily injected with fine gauge needles without compromising the integrity of the gel.

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