Bioengineering Technology R&D and Manufacturing of Hyamed

Contraindications

Prohibited for use in the following groups.

• Persons with known hypersensitivity to streptococcal proteins.
• Those whose injection site has been injected with permanent fillers
• Those with abnormal blood clotting mechanisms, or who are being treated with thrombolytics or anticoagulants
• Those who are prone to keloid formation, hyperplastic scarring or any other healing abnormality
• Patients who are in the midst of a skin herpes episode or skin infection
• Those with a history of severe allergy or a previous history of multiple severe allergies
• Pregnant women, nursing mothers and patients who are minors
• Patients with known hypersensitivity to lidocaine or amide-type local anaesthetics. (for products with lidocaine)

Precautions

• Before treatment, the physician should inform the recipient of the injection of the indications, contraindications, precautions and potential adverse reactions or risks associated with the injection, and ensure that the recipient fully understands and agrees to the use of the product for injection.
• Check the product specification, expiry date and batch number, the integrity of the outer packaging and the sterility markings before opening the outer packaging.
• This product is a Class 3 implantable medical device and should be used with caution after reading the instructions carefully. The product is supplied in a sterile state and does not require re-sterilisation. If the packaging is deformed or damaged, use is prohibited.
• The use of this product is prohibited if turbidity or precipitation is detected.
• Due to the specific nature of the material, each individual package is for one- time use by one person only.
• The syringe needs to be emptied before the start of the injection to ensure that the device can be used normally. If resistance occurs during the pushing process, the device needs to be checked for abnormalities or blockage, and if it cannot be used any further the injection needle needs to be replaced and then injected.
• Avoid wearing make-up for 12 hours after treatment and minimise strenuous exercise, exposure to high sun or heat and alcohol consumption for the frst 24 hours after treatment as these may cause temporary redness, swelling and/or itching at the injection site.
• This is a disposable medical device and all remaining product, syringes and needles must be disposed of after use and given to the medical waste recycling department for special disposal.

Warning and Reminder

• Do not mix this product with other injectable products.
• Do not inject the product into a blood vessel as this may lead to serious adverse events such as embolism, local ischaemia and tissue necrosis.
• Check the product specification, expiry date and batch number before use and read the instructions carefully.
• Prohibit the use of products with solid-liquid separation and/or turbidity of the syringe contents.
• This product is for single use and should not be used repeatedly for sterilization or in separate applications.
• Do not attempt to straighten a bent needle. If the needle is bent or otherwise not functioning properly, it should be replaced with a new one.

Expected Adverse Reactions

• Local reactions associated with the injection process may occur after injection of this product. Usually, injection site reactions (hard nodules, itching, pain, redness, swelling,bruising, petechiae, infection, local inflammatory reaction, formation of scar, nodules, granuloma, allergy, etc.) occur after injection are mostly mild and will subside or disappear on their own without intervention as observation time increases. Occasionally, serious complications such as nerve damage, syncope, hypersensitivity reactions or alergic reactions may occur due to inappropriate injections.
• If alergic reactions such as rash occur during injection, discontinue use.
• The skin barrier system is damaged during the iniection process and infection is possible. Infection can be avoided if the following is done.*Check carefully the integrity of the product packaging before use.*Strictly sterilise the surgical area.*Give appropriate and reasonable post-operative advice and guidance to the patient.