REJURAN Healer

Overview

REJURAN Healer is a sterile, single-use injectable gel based on sodium polynucleotide (PN), made by PharmaResearch Co., Ltd. in South Korea. The manufacturer describes the polynucleotide as purified DNA fragments of a specific size, extracted from wild salmon with its DOT™ technology. The gel is clear, colourless and viscous.

It is delivered into the skin to promote tissue restoration and reconstruction. The manufacturer states that it supports the skin's own regenerative ability, collagen secretion and restoration of the extracellular matrix.

At a glance

• Active ingredient: sodium polynucleotide (PDRN), 20 mg/ml
• Source: salmon
• Lidocaine: not contained
• Application: injection into the dermis by a trained physician (manufacturer's product page: intradermal, 33G needle)
• Pack: two 2 mL syringes with 33G needles, in two blisters per box
• Storage: room temperature (1–30 °C), protected from sunlight
• Shelf life: 24 months from manufacture
• Single use, sterile, do not re-sterilise
• Country of origin: South Korea

Intended use

• Temporary improvement of facial wrinkles in adults (manufacturer's instructions for use DB0229(02)).
• Injection into the mid to deep dermis to promote tissue restoration and reconstruction (instructions for use DB0470).
• Safety and efficacy for lip augmentation have not been established.
• Safety and efficacy of long-term use beyond the period shown in clinical studies have not been established.

How it is used

For use only by physicians trained in the technique. According to the instructions for use:

1. Check that the package is intact and the expiry date has not passed.
2. Bring the product to room temperature before injection.
3. Open the pouch, remove the syringe cap slowly and fit the supplied needle firmly.
4. Disinfect the treatment area thoroughly.
5. Inject slowly into the skin. The amount depends on the area treated.
6. If the needle does not enter easily, do not force it. Withdraw and use another site.
7. After injection, massage the area so the product spreads evenly.
8. Dispose of the syringe and needle as medical waste. Do not reuse a syringe that has been opened or part-used.

The instructions do not state an injection plane, a dose per site or a number of sessions.

Contraindications

• Areas treated with a non-absorbable filler or recently treated with another filler.
• Patients taking NSAIDs, platelet aggregation inhibitors, anticoagulants or immunosuppressants.
• Allergic disease, autoimmune disease, sarcoid granulomatous pathology, or Osler's endocarditis.
• Hypersensitivity to sodium polynucleotide.
• Pregnancy and breast-feeding.
• Children and adolescents.
• Skin damaged by inflammation or infection. Do not use until infection or inflammation is controlled.
• Do not inject into blood vessels, and do not overuse.

Precautions and possible reactions

• Injection into a blood vessel can cause vascular occlusion and tissue necrosis. Avoid vessels at risk.
• Injection in patients with a history of herpetic rash can trigger a recurrence.
• Safety and efficacy are not established in patients prone to keloids, hyperpigmentation or hypertrophic scars.
• Possible reactions: redness, swelling, itching or pain at the injection site, usually lasting about a week. Nodules or hardening, discoloration and lack of effect may also occur.
• Patients should see their physician if inflammation lasts longer than one week or an unexpected reaction appears. Unknown adverse events should be reported to the manufacturer or supplier.

Aftercare advice from the manufacturer

• Avoid make-up for 12 hours after injection.
• Avoid prolonged exposure to sun, UV light, cold or heat (sauna, steam room) for 2 weeks.

Manufacturer and regulatory information

• Manufacturer: PharmaResearch Co., Ltd., Gangneung, Gangwon-do, South Korea.
• Registered in Korea as an approved medical device (MFDS licence No. 14-825) and listed in the Australian TGA register (ARTG 412630).
• This text follows the manufacturer's instructions for use for the REJURAN range (REJURAN, REJURAN i, REJURAN s). Always check the instructions supplied with your batch.