Guna Md-Tissue 5Injectable Vials 2Ml

Description
Medical device useful for facilitating mobility, counteracting the physiological aging of connective tissue, whose primary therapeutic treatment consists of the following functions:
1. Barrier effect.
2. Lubricating activity.
3. Mechanical support in case of ongoing pharmacological therapy.
It is recommended that MD-TISSUE be used by qualified healthcare personnel, in private or public healthcare facilities to:
- create a defense barrier against free radicals;
- counteract the physiological aging of connective tissue;
- alleviate localized pain caused by movement.

Usage methods
MD-TISSUE can be used alone or in combination with all other medical devices belonging to the same line, to create a personalized treatment based on the individual clinical picture.
Regarding its use for the treatment of facial and neck wrinkles and the firming of the subcutaneous connective tissue layer, MD-TISSUE is preferably combined with MD-MATRIX (e.g., MD-TISSUE 2 vials, MD-MATRIX 1 vial/treatment).
The device can be used in patients who need collagen supplementation or topical anti-aging treatment.

Therapeutic protocol:
2 treatments for the first 2 weeks, 1 treatment until symptom improvement (on average 8-10 sessions). Optionally, treatment can continue once every two weeks for a maximum of 10 sessions.
Chronic conditions: continue with 1 treatment per week for a month until symptom improvement, then 1 treatment per month.

• Intradermal route: the application area must be aseptic;
Microinjections: insert the needle at a depth of 1-3 mm, perform microinjections of 0.2 ml – 0.3 ml in the area to be treated.
Tunneling: 0.3 ml is applied along the wrinkle using the tunneling technique. Insert the needle nearly tangentially along the entire length of the zone, then inject and withdraw the needle simultaneously while fanning the product.

• Periarticular route: the application area must be sterile, insert the needle perpendicularly to the skin plane at a depth of 2-4 mm, perform microinjections of 0.3-0.5 ml.

Administration methods:
For this medical device use, the following materials and accessories are recommended:
• Materials to ensure skin asepsis: disposable gloves, iodine-based solution, alcohol solution, sterile gauze, skin spray based on ethyl chloride.
• Microinjection needles: sterile 27 G, 4 mm.
• Tunneling needles: sterile 30 G, 13 mm.
• Syringes: 5 or 10 cc, depending on the amount of solution to be injected.

Components
Porcine-derived collagen.
Excipients: ascorbic acid, magnesium gluconate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, NaCl, injectable water.

Warnings
Single use.
No cases of hypersensitivity have been reported.
Contains animal-derived collagen of porcine species. Patients with proven hypersensitivity to the component or excipients must undergo prior injection test on the arm and be monitored for one hour.
Slight redness at the injection site may be due to the mechanical effect of the needle or a skin reaction.
The application may cause symptoms of burning/pain at the injection sites, which generally resolve within 5-10 minutes after treatment.
Skin cleaning/disinfection before and after application is necessary.
Pathogenic bacteria could produce an abscess at the injection site.
Keep out of reach and sight of children.
Do not use after the expiration date.
Use the product immediately after opening.
Do not use if the seal is broken or tampered with.
After opening, the contents of the vial must be injected immediately.
Do not use if packaging is damaged.

Storage
Store at a temperature between 2°C and 30°C, protect from sunlight and freezing.
The expiration date refers to the product in intact packaging, properly stored.

Format
Pack of 5 sterile vials of 2 ml