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Product:

SAYPHA® FILLER

Manufacturer: Croma
Active Substance(s) : Hyaluronic acid
Strength: 23mg/ml
Pack Size: 1-1ml prefilled syringe
Accessories: Package insert, 2-27G 1/2 needles, 2 traceability labels
Other Known Names: PRINCESS® FILLER
 
 
 
 

Saypha Filler is a temporary dermal implant that comes in a clear, viscoelastic, and homogenized gel solution. It is made of hyaluronic acid (HA), an essential component of the skin that plays a role in maintaining moisture, elasticity, and firmness. Saypha Filler is indicated for combating different signs of skin aging, such as sun damage, fine lines and wrinkles, and dehydrated and sagging skin.

Composition

Saypha Filler contains 23 mg/mL hyaluronic acid, cross-linked using 9% BDDE, in a phosphate buffered saline (pH 6.8-7.6 q.s.) The main ingredient is obtained from Streptococcus equi bacteria.

What is Saypha Filler formulated to do?

Saypha Filler is biocompatible and can be injected into various regions in the face to, as mentioned above, combat and rectify different signs of aging. It contains synthetic hyaluronic acid that is created with Supreme Monophasic and Reticulated Technology (SMART). The resulting HA molecules have a 3D gel structure that can resist degradation inside the skin for long periods of time. Because its hyaluronic acid content attracts and retains water when implanted in the skin, Saypha Filler significantly improves the appearance of glabellar lines, marionette lines, perioral wrinkles, and nasolabial folds.

Manufacturer

Saypha Filler is designed and manufactured by Croma-Pharma GmbH, an Austrian company with over 40 years’ experience in the pharmaceutical industry and expertise in skin care and dermal filler injectables.

Origin

This product originates from Vienna, Austria, which is where Croma-Pharma GmbH has its headquarters.

Common side effects associated with the treatment

Consult the package insert for a complete list of side effects related to this filler. Some of the common side effects reported by study participants and actual patients treated include the following:

  • Redness
  • Swelling
  • Bruising
  • Itching
  • Local tenderness or pain
  • Formation of bumps, lumps, or nodules

This may not be a complete list of side effects. Refer to the package insert for a full list of side effects, warnings, and contraindications. Patients should be informed of all possible side effects, contraindications, and precautions prior to treatment. If any adverse effects are prolonged or worsen, your patient should contact you or another medical professional.

Precautions and contraindications

This dermal implant is contraindicated in individuals with a known hypersensitivity to any component of the medication—such as bacterial proteins and sodium hyaluronate (hyaluronic acid), to name a few. This product has not been tested on patients younger than 18 years of age, those with a history of anaphylaxis, and pregnant and/or lactating mothers.

Packaging information

Saypha Filler is a sterile, viscoelastic gel solution that comes in graduated, ready-to-use, and disposable syringes. Check the contents of the package prior to use. Discard this product if the packaging is opened or damaged. Enclosed within this product’s packaging are two sets of traceability labels; one of these must be attached to the patient’s record, and the other must be given to the patient. Additionally, a package insert also comes with the packaging of this product; as mentioned above, this insert contains a full list of side effects, warnings, and contraindications.

Frequently Asked Questions

Which skin type is it good for?

Saypha Filler can be used on all skin types, from dry to oily, normal, sensitive, and acne-prone skin. Saypha Filler is also beneficial on dry, dull, and dehydrated skin with visible signs of aging. 

How do I use this product?

  • Only use Saypha Filler on clean, healthy, and non-inflamed skin. If the skin that is going to be treated is inflamed, wait until said inflation has subsided until proceeding with the injection.
  • Disinfect the treatment area with a suitable antiseptic solution.
  • If desired, choose the Saypha Filler variant with added lidocaine to reduce patient’s discomfort.
  • With the 27G ½” needle provided in Saypha Filler’s packaging, slowly inject the content of the syringe using appropriate injection techniques.
  • After the injection has been completed, lightly massage the treated area to distribute the product evenly.

What is in the box?

  • One sterile, prefilled syringe that contains 1ml of this solution
  • Two 27g ½” needles
  • Traceability labels
  • Package insert

How long do the effects last?

The unique formulation of Saypha Filler’s hyaluronic acid—which, as mentioned above, is made with Supreme Monophasic and Reticulated Technology (SMART)—allows it to resist rapid absorption and degradation when implanted in the skin, thereby prolonging its effects. The duration of effect of Saypha Filler is anywhere between six to 10 months.

How should the product be stored?

Due to the sensitive nature of Saypha Filler’s ingredients, you must keep this product away from heat and freezing temperatures. Store it in a cool, dry place with a temperature between 2℃ and 25ºC.  Refrigeration is not required for this product.

When does the product expire?

  • This product can remain viable two years after its manufacturing date.
  • Use a package of Saypha Filler before the expiry date listed on its package labelling.

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