Vitaran I (2x1ml)

What it is

Vitaran I is a CE-marked (CE 2265) polynucleotide intradermal gel for injection into the dermis, supplied as 2 pre-filled 1 ml syringes.

Intended purpose (per instructions for use)

The product is a moisturising and trophic substance and is therefore used mainly to improve the turgidity, suppleness and tonicity of the skin. These effects can also facilitate remodelling of areas with a high fibrous content, such as striae and scars, within treatment protocols customised by the treating physician.

Composition

Polynucleotide sodium 20 mg/ml, buffer q.s.

Treatment

• Format: 2 × 1 ml pre-filled syringes, 1 sterile 34G needle per syringe.
• Inject slowly into the dermis; the injection volume can be varied depending on the treatment area. The manufacturer specifies no fixed treatment course; the number of treatments is determined by the practitioner.

Important to know

For use by trained medical personnel only; the treatment must be performed by a qualified physician. Do not use in patients taking NSAIDs, platelet aggregation inhibitors, anticoagulants or immunosuppressants, in allergic or autoimmune disease, in pregnant and breastfeeding women, in children and adolescents, or on skin damaged by inflammation or infection. Do not inject into blood vessels. The safety and efficacy for lip augmentation has not been established.

Storage and shelf life

Single use only; do not resterilise. Store at 1–30 °C, protected from sunlight. Shelf life 36 months from the date of manufacture.

Documentation and traceability

CE-marked (CE 2265 syringe, CE 0068 needle). Manufacturer: BR PHARM Co., Ltd., South Korea. Authorised representative in the EU: KTR Europe GmbH, Germany. See the attached instructions for use.

Composition: Polynucleotide sodium 20 mg/ml, buffer q.s. — 2 × 1 ml pre-filled syringes per pack.

Polynucleotide sodium 20 mg/ml. Inject slowly into the dermis (intradermally) after disinfecting the treatment area; the injection volume can be varied depending on the treatment area. If injection is difficult, do not increase the pressure on the plunger – treat another site instead. After treatment, gently massage the skin to spread the injected solution evenly. A sterile disposable 34G needle is provided (1 per syringe); attach the needle to the syringe and pull in the opposite direction to remove the needle cap. Use at room temperature; store at 1–30 °C. The manufacturer specifies no fixed treatment course; the number of treatments is determined by the practitioner. See the attached instructions for use.