Aphranel MagicCrystal-Patient Information Leaflet

1.       About Aphranel MagicCrystal

1.1.       Introduction

This leaflet is designed to give you useful information about Aphranel MagicCrystal by MOYOM but is not intended to provide advice regarding any specific case. It does not replace the need for a thorough consultation and you should seek the advice of a suitably qualified medical professional if you wish to be treated with this product.

−         Only you and your healthcare professional can decide whether Aphranel MagicCrystal is right for you. Other treatment options may also be discussed during your consultation.

−         Please read all the information in this guide and discuss any questions with your healthcare professional before you are treated with Aphranel MagicCrystal.

−         Keep this information, You may want to read it again.

1.2.       Name or Trade Name

Generic Name: Injectable CaHA Microsphere Hydrogel Filler

Trade name: Aphranel MagicCrystal

What is Aphranel MagicCrystal?

Aphranel MagicCrystal is a dermal filler containing nature-identical mineral calcium hydroxylapatite (CaHA) suspended in a gel matrix that is mainly made up of water (sterile water for injection) together with glycerin and sodium carboxymethylcellulose (NaCMC)

 

1.3.       How does Aphranel MagicCrystal work?

After injection, the correction is immediate as a result of the high elasticity of the NaCMC gel. The gel matrix is gradually degraded. The CaHA remains in place until it also is degraded over time. The result is an immediate and long-term, but not permanent, smoothing of wrinkles and folds, enhancement of facial contours and improvement of skin quality.

1.4.       What is Aphranel MagicCrystal made of?

Aphranel MagicCrystal is an implant that is, over time, being taken up by surrounding cells/tissue and subsequently broken down and dissolved. It is used to replace lost volume, thus achieving soft tissue enhancement. The principal components consist of CaHA particles suspended in a gel matrix made up as follows.

−         28% 25-45um CaHA particles (w/w [by weight])

−         72% Gel matrix(w/w [by weight]), which consists of sterile water for injection, glycerin and non-crosslinked sodium carboxymethylcellulose(NaCMC)

1.5.       What is Aphranel MagicCrystal used for?

Aphranel MagicCrystal is injected into the skin through a needle to plump the skin and add volume to smooth wrinkles and folds of the face, enhance facial contours, stimulate the production of collagen and elastin, and improve the quality of the skin. Your healthcare professional will inject the product into your skin to make wrinkles shallower and less visible. However, Aphranel MagicCrystal will not correct the underlying causes of the wrinkles and folds. Aphranel MagicCrystal is for aesthetic purposes only.

1.6.       What will Aphranel MagicCrystal accomplish?

Aphranel MagicCrystal will provide a temporary lifting effect, enhance contours, smooth wrinkles and improve skin quality, thus giving a more youthful appearance.

1.7.       How long do treatment effects last?

Studies have shown that when the product is used for the purposes listed above, the effect will last 6-12 months in most people. The durability of correction provided by CaHA depends on multiple factors, including injection technique, site of material placement, patient age, and metabolism.

1.8.       Which anatomic regions can be treated with Aphranel MagicCrystal?

Aphranel MagicCrystal is intended to: Treat the moderate to severe facial wrinkles and folds, such as nasolabial folds

1.9.       For whom is Aphranel MagicCrystal suitable?

Aphranel MagicCrystal may be used in adult people considering the indications and contraindications, etc., stated in the instructions for use. Please seek the advice of a suitably qualified healthcare professional to find out whether Aphranel MagicCrystal is right for you.

1.10.    In what kind of environment and by whom should Aphranel MagicCrystal be applied?

Aphranel MagicCrystal is only to be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law.

1.11.    How is Aphranel MagicCrystal sterilized?

Aphranel MagicCrystal is provided in a pre-filled syringe sterilized by moist heat. It is for single use only.

2.       Safety Information

Are there any reasons why l should not receive Aphranel MagicCrystal?

Aphranel MagicCrystal is contraindicated (must not be used) in the following cases:

•         In people with active or chronic skin inflammation or infection in or near the treatment area.

•         In people with severe allergies and a history of anaphylactic or allergic reactions.

•         In people with a tendency to develop skin inflammation or scars.

•         In the presence of foreign bodies such as liquid silicone or other particulate materials.

•         In people with bleeding disorders.

•         In people with known hypersensitivity to any of the components.

•         In people with systemic disorders that cause poor wound healing or could have a detrimental effect on the tissue over the implant.

•         In areas of the body, which are poorly covered by soft tissue and which are not well supplied with blood

•         In people younger than 18 years.

•         In breast feeding and pregnant women.

2.1.       It must not be injected into:

•         The upper layers of the skin or be used as a skin replacement because this could lead to complications such as fistula formation (hole through the skin), infections, extrusions (the product emerges through the skin onto the surface), nodule formation and hardening of the skin (induration).

•         Frown lines and nose since there is a risk of necrosis (tissue death) and arteries in the eye's retina becoming blocked.

2.2.       What are some warnings to consider?

•         It is important to share your medical information with your healthcare professional. Together, you can make an informed decision as to whether or not Aphranel MagicCrystal is right for you. There are risks associated with using the product, which might or might not apply in your case.

•         Accidental injection of Aphranel MagicCrystal into a blood vessel is a very rare event. Still, it can lead to serious and/or permanent complications such as embolization (blocked vessel by-product) or thrombosis (local coagulation or clotting of the blood in a part of the circulatory system, i.e. veins), occlusion or blockage of vessel ischemia (restricted blood supply to blood vessels), or infarction (tissue death), Complications reported after facial injections include vision abnormal ies, blindness, stroke, temporary scabs, and permanent scar of the skin. If you experience changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness of your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness or confusion), white appearance of the skin or unusual pain during or shortly after treatment, notify your healthcare professional immediately.

•         Aphranel MagicCrystal should not be injected in people taking aspirin permanently. Filler should not be injected in people taking medicines that could inhibit the healing process.

•         Aphranel MagicCrystal should not be used in any person with active skin inflammation or infection in or near the treatment area until the inflammation or infection has been controlled.

•         Some injectable implants have been associated with hardening of the tissues at an injection site, migration of particles from an injection site to other parts of the body and/or allergic or autoimmune reactions.

•         As with any implant material, possible adverse reactions which may happen include, but are not limited to, the following: inflammation, infection, fistula formation, extrusion, hematoma, seroma, induration formation, inadequate healing, skin discolouration and inadequate or excessive augmentation.

2.3.       Which topics should I discuss with my healthcare professional as a matter of precaution?

•         Tell your healthcare professional about medicines you are taking because if you are using medications that can prolong bleeding, such as aspirin or warfarin, you may, as with any injection, experience increased bruising or bleeding at the injection site.

•         Tell your healthcare professional if you have a history of herpes because it can become reactivated by injection of Aphranel MagicCrystal.

•         Tell your healthcare professional if you have concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical or chemical peeling procedures. The safety of Aphranel MagicCrystal with these procedures has not been evaluated in controlled clinical trials.

•         You should limit the exposure of the treated area to sun or heat for 24 hours after treatment or until any initial swelling and redness has disappeared.

•         The CaHA microspheres of Aphranel MagicCrystal are visible in CT scans and may also be visible in X-rays and MRI scans. Tell your healthcare professional, as well as your radiologists, that you have had Aphranel MagicCrystal injected into your face. Hence they are aware it is present when they are looking at your CT scans or X-rays. Consider presenting your implant card to your healthcare professional, as well as your radiologists for information.

2.4.       Which side effects may occur?

•         Injection-related reactions, including induration, swelling, pain, bruise, itching, inflammation hematoma, bleeding and erythema, may occur at the site of the injection. These usually disappear spontaneously within one to two weeks.

2.5.       What can l do to prevent or reduce side-effects?

Your healthcare professional will advise you on what to do after the procedure to promote normal healing and avoid complications. General guidelines include the following:

•         You must avoid applying make-up (including skin care products) for at least 24 hours.

•         Repeatedly apply cool compresses to the injected areas needed during the first 24 hours after injection.

•         Avoid the sun, tanning (ultraviolet) lamps, sauna and intense treatments in the area, which was treated with Aphranel MagicCrystal.

•         If palpable nodules appear, massage the area gently.

•         Rest your face for a week by talking, smiling, and laughing as little as possible.

•         You must avoid drinking alcohol for 24 hours before and after treatment. Alcohol may cause the blood vessels to dilate and cause more bruising.

•         You should avoid strenuous physical activity for 24 hours after treatment.

•         You may be asked to stay for a certain time on the HCP premises to identify any potential undesirable side effects.

2.6.       Which side-effects and residual risks may occur in spite of correct treatment and in spite of all precaution and measures being taken?

 In the course of its lifetime, all risks that may occur in connection with Injectable CaHA Microsphere Hydrogel Filler are analyzed and reduced as far as possible. This so-called risk management spans all steps from the design and production of the Injectable CaHA Microsphere Hydrogel Filler to the disposal of the used or wasted syringe and even to its degradation in the body.

However, after all possible measures have been taken, some risks inherent to treatment with Injectable CaHA Microsphere Hydrogel Filler and the biology of our skin still remain.

The patients must be informed that, as with any implant material, there are possible residual risks, contraindications, information, and any undesirable side effects and adverse reactions. The contents are conveyed to the patient in this part. Most of the listed problems are very rare; nevertheless, they are listed as follows for patient information. 

•         Adverse events seen in a clinical trial with Injectable CaHA Microsphere Hydrogel Filler were generally expected, mid in nature, and short in duration.

•         The following adverse events were reported during clinical trials performed with the Injectable CaHA Microsphere Hydrogel Filler: induration, swelling, pain, bruise, itching, inflammation hematoma, bleeding and erythema.

•         The following adverse events have been identified during clinical evaluation, including adverse events and side effects from literature and incidents from competent authorities’ database: obstruction/occlusion, tightness, fever or nausea, nodule, necrosis, granuloma, hypersensitivity/allergic reaction, inflammation,  cellulitis, deposits, fibrosis, ischemia, skin Inflammation/ irritation, subcutaneous nodule, skin discolouration, angioedema, rash, redness, infection, bump, migration, leakage or rupture, blindness, stroke, asymmetry, skin discolouration, ulceration.

The following interventions have been reported: antibiotics, anti-inflammatories, corticosteroids, antihistamines, analgesics, massage, warm compress, excision, drainage, and surgery. This information does not constitute and is not intended to be medical advice, a recommendation on how to treat an adverse event or an exhaustive list of possible interventions. Physicians should evaluate each case individually and independently determine, based on their professional experience, what treatment(s) are appropriate, if any, for their patients.

2.7.       What should l do if l have problems after Aphranel MagicCrystal treatment?

Suppose you believe you have experienced a serious problem related to your Injectable CaHA Microsphere Hydrogel Filler treatment. In that case, you should call your healthcare professional.

Any side effects at the injection site which last for more than 2 weeks should be reported to your healthcare professional.

Immediately report any side effects such as changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness or confusion), white appearance of the skin, unusual pain during or shortly after treatment. Your healthcare professional may refer you for appropriate treatment. The relevant contact information is included on your implant card.

You may also contact Moyom to report any side effects via:

 Aphranel-MagicCrystalFiller-Safety@mybiotec.com

3.       Additional Information

3.1.       lmplant Card

After the injection, your doctor will provide you with an implant card. This card contains all information related to your injection:

 

Number	Symbols	Details
1		Patient name
2		Date of implantation
3		Name and address of the physician
4		Number of injections
5		Total volume injected
6		Injection site(s)
7		Information website for patients

Keep this card with you and show it to your healthcare professional during any other appointments. informationabout previous treatment must be shown to your healthcare professional before new treatment is started.

3.2.       Electronical Patient Information (Pl)

A printable PDF version of the patient information leaflet in your local language can be found on the following website: www.aphranel.com. For the most recent version of the patient information leaflet please always refer to the website.

4.       Legal Manufacturer/Authorized Representative

Shanghai Moyom Biotechnology Co., Ltd.

Adress: Room 201, 206-210, Building 3, No. 999, Jiangyue Road Minhang District, Shanghai, China

Tel: +86 021-26018793

Fax: +86 021-26018793

Emergo Europe B.V.

Westervoortsedijk 60, 6827 AT Arnheim, The Netherlands

Tel:(31)(0)70 345-8570

Email: EmergoVigilance@ul.com

Aphranel MagicCrystal is a registered trademark of Shanghai Moyom Biotecnology co, Ltd,.

 

Used Harmonised Standards & Common Specifications:

All harmonised standards and common specifications applied are listed within the Summary of Safety and Clinical Performance.

 

The current Summary of Safety and Clinical Performance can be found in the European database on medical devices (Eudamed) under the URL: https://ec.europa.eu/tools/eudamed.Please open the option "Search for Devices" and enter in the search field "Basic UDI-DI/EUDAMED DI" the number 697244792MY001LY. Until EUDAMED is fully functional the SSCP may be requested via Aphranel-MagicCrystalFiller-Safety@mybiotec.com.

 

Version Number:A/0

Issue Date: 2024.11.02