Product information - Kingdom of Saudi Arabia

1. What TEOSYAL® products are and what they are used for

1.1 Description of TEOSYAL® products

TEOSYAL® products are dermal fillers which are sterile injectable viscoelastic hyaluronic acid gels (of non-animal origin) and containing lidocaine (0.3%) to help reduce discomfort during injection.

The composition of the TEOSYAL® PureSense products is presented in the below

• TEOSYAL® PureSense Redensity 1:

  • Hyaluronic acid: 15 mg/ml

  • Phosphate buffer: N/A

  • Supplemented Phosphate Buffer: q.s. ad 1 ml or 3 ml

  • Lidocaine: 0.3% by mass

• TEOSYAL® PureSense Redensity 2:

  • Hyaluronic acid: 15 mg/ml

  • Phosphate buffer: N/A

  • Supplemented Phosphate Buffer: q.s. ad 1 ml

  • Lidocaine: 0.3% by mass

• TEOSYAL® PureSense Ultra Deep:

  • Hyaluronic acid: 25 mg/ml

  • Phosphate buffer: q.s. ad 1.2 ml

  • Supplemented Phosphate Buffer: N/A

  • Lidocaine: 0.3% by mass

• TEOSYAL® RHA 1:

  • Hyaluronic acid: 15 mg/ml

  • Phosphate buffer: q.s. ad 1 ml

  • Supplemented Phosphate Buffer: N/A

  • Lidocaine: 0.3% by mass

• TEOSYAL® RHA 2:

  • Hyaluronic acid: 23 mg/ml

  • Phosphate buffer: q.s. ad 1 ml

  • Supplemented Phosphate Buffer: N/A

  • Lidocaine: 0.3% by mass

• TEOSYAL® RHA 3:

  • Hyaluronic acid: 23 mg/ml

  • Phosphate buffer: q.s. ad 1 ml

  • Supplemented Phosphate Buffer: N/A

  • Lidocaine: 0.3% by mass

• TEOSYAL® RHA 4 :

  • Hyaluronic acid: 23 mg/ml

  • Phosphate buffer: q.s. ad 1.2 ml

  • Supplemented Phosphate Buffer: N/A

  • Lidocaine: 0.3% by mass

• TEOSYAL RHA KISS®:

  • Hyaluronic acid: 23 mg/ml

  • Phosphate buffer: q.s. ad 0.7 ml

  • Supplemented Phosphate Buffer: N/A

  • Lidocaine: 0.3% by mass

1.2 Categories of users and consumers

To minimize the risk of potential complications, the TEOSYAL® products should be administered only by healthcare professionals who received appropriate training on the conditions to safely use the device. The product should not be injected in patients who are less than 18 years old and having any of the contra-indications referenced in the instruction for use of the products.

1.3 Expected performance of the products

The following aesthetic results are expected when you receive an injection of TEOSYAL® products:

• TEOSYAL® PureSense Redensity 1: Indicated for the improvement of wrinkles, skin rehydration, as well as for the correction of withered skin marked by signs of ageing, on the face, crow’s feet, neck and neckline.

• TEOSYAL® PureSense Redensity 2: Indicated for the correction of fine lines/wrinkles affecting a withered skin marked by signs of ageing and the treatment of the under eyes circles, including tear trough.

• TEOSYAL® PureSense Ultra Deep: Indicated for facial contour remodelling, volume restoration/augmentation and minor tissue ptosis correction, in areas such as cheeks or upper cheeks. It is also indicated for the filling of deep wrinkles and folds in thick skin areas, such as nasolabial folds.

• TEOSYAL® RHA 1: Indicated for the even filling of fine superficial wrinkles (such as perioral rhytids, upper lip border and philtrum).

• TEOSYAL® RHA 2: Indicated for filling linear facial wrinkles, skin creases such as mild or moderate nasolabial folds.

• TEOSYAL® RHA 3: Indicated for the filling of deep facial wrinkles, such as moderate to severe nasolabial folds.

• TEOSYAL® RHA 4 : Indicated for the filling of deep wrinkles and folds in thick skin areas, such as moderate to severe nasolabial folds.

• TEOSYAL RHA KISS®: Indicated for filling linear facial wrinkles, skin creases such as mild or moderate nasolabial folds.

2. What you need to know before you are given TEOSYAL® products

2.1 Contra-indications

Are there any reasons why you should not receive TEOSYAL® products?

Prior to any injection of TEOSYAL® products, your injector must ask you about your past medical history and your current condition or medication that could affect the procedure. So, you should inform the injector about recent or current pathologies, as well as chronic illnesses, chronic or current allergies, and chronic or ongoing treatments.

You must report to your injector, aesthetic treatments performed previously. Due to the absence of data concerning the possible interactions with other filling implants (HA filling implants or other, possibly permanent), your injector will assess and decide on further injections with other filling implants, depending on the nature and the time of the previous injection.

Especially, you should not use TEOSYAL® products if: - You have any cutaneous disorders, inflammation, or infection at or near the treatment site. Injection procedures can lead to reactivation of latent or subclinical herpes viral infections. - You are allergic to hyaluronic acid, with a history of severe allergy or anaphylactic shock. - You are allergic to lidocaine and/or amide local anesthetic agents. - you recently had a peeling, laser or ultrasound-based treatment. - you have any autoimmune diseases. - you have any cardiac diseases and/or undergoing treatment for heart disease (beta blockers). - you have any hepatocellular insufficiency and/or undergoing treatment for a liver disease. - you are suffering from epilepsy or porphyria. - you are pregnant, or a breast-feeding mother, or a patient less than 18 years old.

2.2 Precautions

Are there precautions that you should discuss with your injector?

Your injector should inform you about the indications, expected outcomes, contraindications, precautions, and potential side effects.

Before the injection, the following precautions should be considered: - Avoid getting an injection if you have had a dental procedure within the previous 15 days. - Avoid taking aspirin, anti-inflammatory drugs, anticoagulants, and vitamin E during the week prior to the injection. Ask your doctor for advice prior to stopping any treatment. - Avoid drinking alcohol or exposing yourself to strong sunlight the day before and the day of the injection. - Remove your make-up thoroughly prior to the injection.

After the injection, the following recommendations must be considered: - Within 12 hours following the injection: do not apply make-up, avoid any violent effort. - During the week following the treatment: avoid drinking alcohol, prolonged exposure to the sun or UV rays, temperatures below 0°C, as well as the practice of sauna or hammam. - Within 15 days following the treatment: do not perform dental or other aesthetic procedures

2.3 Possible side effects (risks linked to the use of TEOSYAL® products)

What possible reactions could occur following the injection?

As with all hyaluronic acid-based products, the following side effects can be seen after the injection of TEOSYAL® PureSense products:

• Common manifestations: pain at the point of injection, tenderness, redness/erythema, bruising/haematomas, swelling/oedema, firmness/induration, lumps/bumps, itching, dyschromia (including Tyndall effect / discoloration).

• Less common manifestations: inflammatory reactions, infection (including localised or generalised infection and abscesses), loss of sensitivity around the injected area or temporary paraesthesia, risk of allergy (including hypersensitivity, dermatitis allergy, urticaria), nodules (possibly granulomas), implant migration.

• Rare but serious adverse events may occur:

  • Intravascular injection may lead to embolization, occlusion of the vessels, ischemia, skin/tissue necrosis, temporary or permanent vision impairment (including blindness), cerebral ischemia/haemorrhage leading to stroke, infarction.

  • Immediate hypersensitivity up to Angioedema and anaphylactic shock.

Before the treatment, the practitioner must instruct the patient to report any adverse event described above or not, or persisting beyond one week.

The practitioner will then inform the product distributor and/or manufacturer (medical@teoxane.com) within the shortest time possible. The practitioner should use or prescribe an appropriate treatment.

Any serious incident that has occurred in relation to the device should be reported to medical@teoxane.com and the Saudi Food and Drug Authority.

Reporting of side effects: In case of dissatisfaction with the expected aesthetic result or if any side effects occurred following treatment with a TEOSYAL® PureSense product, you should immediately contact your injector, TEOXANE Laboratories and Saudi Food and Drug Authority:

00 41 (0) 22 344 96 36 - medical@teoxane.com

Most of the reactions described above are gone within one week after the injection, however, you must see a doctor if your symptoms persist. 3. Expected lifetime of the products and any necessary follow-up

The lifetime of the product is understood as the duration of the aesthetic effect. It depends on several factors including skin type, the severity of the wrinkle to be treated, the injected area, the injected volume, the patient’s physiology, and lifestyle.

Your injector will choose the product suitable for injection according to your needs and taking into account your request and will tell you if a touch up session may be required for optimal results.

The estimated lifetime of TEOSYAL® PureSense products are provided in the below

Estimated in vivo lifetime of at least 3 months:

• TEOSYAL® PureSense Redensity 1

Estimated in vivo lifetime of at least 12 months:

• TEOSYAL® PureSense Redensity 2

• TEOSYAL® RHA 1

Estimated in vivo lifetime between 12 to 18 months:

• TEOSYAL® RHA 2

• TEOSYAL® RHA 3

• TEOSYAL RHA KISS®

Estimated in vivo lifetime between15 to 18 months:

• TEOSYAL® PureSense Ultra Deep

• TEOSYAL® RHA 4

4. Reference to any harmonized standard and common specifications

Some harmonized standards and Common specifications apply to the TEOSYAL® PureSense products. The complete list is available in the Summary of Safety and Clinical Performance (SSCP) which is available on Eudamed at the following website: ec.europa.eu/tools/eudamed/#/screen/home.

History of the document:

Teoxane Dermal Fillers Instruction for patients_KSA_EN_Rev00 : Revision date : 13.06.2023

Teoxane Dermal Fillers Instruction for patients_KSA_AR_Rev00 : Revision date: 13.06.2023