Composition: 

  • Storage between 2ºC and 25ºC

  • Do not freeze

  • Fragile  

  • Disposition 

  • Used needles and syringes must be disposed of according to standard medical practices and local regulations. 

Patients must be informed about the common adverse effects reported for hyaluronic acid injectable implants, which may occur immediately or may be delayed. These include, but are not limited to: 

 

  • Inflammatory reactions (redness, erythema, oedema) which may be associated with pain or itching.   

  • Hematomas  

  • Induration, migration or nodules at the injection site. 

  • Poor effect or weak filling effect and loss of sensitivity at the site of injection. 

  • Necroses in the glabellar region, abscesses and granuloma. It is advisable to consider these potential risks. 

  • Treatment site reactions typically resolve within 24-48 hours.  Other adverse effects generally resolve within 2-4 weeks.  

  • Patients should be advised to promptly report attending any evidence of a serious adverse effect or any adverse effect not mentioned in this leaflet to the attending physician. 

  • Any other undesirable side effects associated with injection of HB FILL 18, 23, 26 must be reported to the local distributor and/or directly to the manufacturer. METHOD OF USE Prior to treatment 

  • Handle in accordance with standard medical practices and local regulations. For a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for dermal filling.  

  • Carefully inspect visually the gel before injection. Subsequent treatments may be required to obtain optimal results.  Allow for at least seven days between treatments, to enable effective evaluation of the implantation outcome.  

  • Before starting the treatment, patients should be informed of the products indications, incompatibilities, contra-indications and potential side effects. A full patient history should be obtained and the region to be treated should be fully appraised.  

  • Assess the patient’s need for managing pain and apply, if necessary, the most appropriate form of anesthetic.  In the event of anesthetic administration, apply ice to the area to reduce local swelling and distention. 

  • Thoroughly wash the treatment area with soap and water and disinfect with an alcohol swab. Assembly and handling of the needle HB FILL 18, 23, 26 it is advisable to use with 27G thin-wall needles. Needle occlusion may occur more frequently if smaller diameter needles are used. 

  • Do not overcorrect.

  • Do not inject into blood vessels (intravascular).  

  • Do not use after the expiry date.  

  • Do not use if the label is damaged.  

  • Do not use if the package is open or compromised. 

  • Do not re-sterilize.  

  • Do not modify the product; modification may affect its sterility and performance.  

  • Do not use if device damage is suspected. 

  • Do not use if particles, coloration, turbidity, or separation are visible in the gel. 

  • Do not inject an amount greater than 20 ml per 60 kg body mass per year. Precautions for use  

  • HB FILL 18, 23, 26 is indicated for intra-dermal injection only.  •

  • HB FILL 18, 23, 26 is to be used by specialized physicians in dermatology only. The physician must be familiar with the product, implantation procedure and techniques. In using the device, clinical judgment must be made regarding its application. 

  • As a matter of general principle, injection of a medical device is associated with a risk of infection.  

  • Only syringe content and injection path are sterile.  

  • HB FILL 18, 23, 26 is to be used under sterile conditions only.  

  • Use with caution in patients currently on immunosuppressive therapy. The physician shall therefore decide on the indication on a case-by-case basis, according to the nature of the disease and its corresponding treatment, and shall ensure the specific monitoring of these patients. In particular, it is recommended that these patients undergo a preliminary dual test, and to refrain from injecting the product if the disease is active.  

  • Patients on anti-coagulation medication must be warned of the potential increased risks of heamoatomeas following injections. 

  • Use with caution when injecting in proximity to permanent filling implants. There is no clinical data (efficiency and tolerance) about injection of HB FILL 18, 23, 26 into an area, which has been treated with a permanent implant. 

  • Avoid injecting through scar tissue and/or significantly compromised tissue.  

  • Injection into inflamed or infected tissue may result in tissue damage or loss. 

  • Hematomas or seromas may require surgical drainage.  

  • Major hypersensitivity reaction, inflammation and infection may require implant removal.  

  • Patients with a record of streptococcal disease (such as recurrent sore throats or acute rheumatic fever), should be tested before treatment. If rheumatic fever is accompanied with heart complications, the product should not be used.  

  • Injection of the product may be accompanied with mild discomfort; administration of anesthetics should be considered. 

  • As with all transcutaneous procedures, injection of the product carries a risk of infection. The usual precautions associated with injectable material should be followed.  

  •  For injection into the eyelids. The application of HB FILL 18, 23, 26 in the under-eye area is to be performed only by specialists specifically trained in this technique that have a sound knowledge of this the area’s physiology.

  • For injection into the epidermis. 

  • For patients with a known sensitivity to any of the product components.  

  • For patients suffering from an acute or chronic inflammation or infection in the area to be treated.  

  • In patients with a tendency to develop inflammatory skin conditions or hypertrophic scarring.  

  • For patients with unhealthy or poorly vascularized tissue or with systemic disorders affecting wound healing.  

  • For patients suffering from skin disease or abnormal skin conditions. 

  • For patients with a history of anaphylactic reactions. 

  • For patients treated with aspirin or any other medicine which can affect the healing process.  

  • For use in regions containing foreign bodies (e.g., silicone, other particulate materials).  

  • For use in area presenting cutaneous inflammatory and/or infectious process (acne, herpes, etc.…).  

  • For use simultaneously with laser treatment, deep chemical peels or dermabrasion. For surface peels, it is not recommended to inject HB FILL 18 if the inflammatory reaction generated is significant.  

  • For patients with autoimmune diseases.  

  • For patients suffering from porphyria.  

  • For patients suffering from untreated epilepsy.  

  • For use in breastfeeding or pregnant women.  

  • For use in patients below the age of 18.  

HB FILL 18  - Sodium Hyaluronate cross-linked 18 mg Phosphate buffer saline  

Indications
HB FILL 18 is a gel of cross-linked hyaluronic acid indicated for superficial lines, fine to moderate wrinkles and minor skin damages.  
The product can be used on wrinkles, lines and creases around the mouth. It is to be injected into the superficial and mid dermis (recommended needles is 27G).  


HB FILL 23 - Sodium Hyaluronate cross-linked 23 mg Phosphate buffer saline 
 
Indications  
HB FILL 23
is indicated for the correction of deep and severe facial wrinkles and folds.  
It is to be injected into the deep dermis (recommended needles is 27G). 


HB FILL 26 - Sodium Hyaluronate cross-linked 26 mg Phosphate buffer saline 
 
Indications  
HB FILL 26
is a gel of cross-linked hyaluronic acid indicated for volume augmentation and facial shape restoration. The product is also indicated for lips contour and volume.  The product can be used on severe wrinkles. 
 It is to be injected into the deep dermis or subcutaneously for volume augmentation and mid to deep dermis for injection into lips (recommended needles is 27G). 

HB FILL 18, 23, 26 - is an injectable sterile, pyrogen-free gel composed of a cross-linked hyaluronic acid from a non-animal origin in a phosphate buffer saline solution. The gel is latex free, viscoelastic, clear, colorless and biodegradable.  HB FILL 18, 23, 26 is intended for facial tissue augmentation. Package Content Each package contains one disposable graduated and pre-filled syringe with HB FILL 18, 23, 26 gels.  One syringe contains 1.0 ml of HB FILL 18, 23, 26. The content of HB FILL 18, 23, 26 syringes is sterilized by moist heat. The accuracy of syringe graduations is ±0.020 ml. HB FILL 18, 23, 26 packages is supplied with instructions for use leaflet and two patient labels. 

Description 

Contra-indications HB FILL 18,23,26  is contraindicated for the following: 

UNDESIRABLE EFFECTS 

Warnings

Storage 

Post injection care 

HB fill - products  Only for professional use

Patients should be advised to avoid extreme activity, and exposure to sunlight and tanning lamps or extreme weather conditions for 24 hours. Patients should be instructed to apply an ice pack or cold compress to the treated area for 24 hours post- treatment. Patients should be advised to limit talking, smiling and laughing for one week after the procedure. Patients treated at the mouth area should be advised to rinse their mouth with a saline solution every 3-4 hours, for one week post-treatment. If needed, oral analgesics can be used.

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Dr. Korman Laboratories Ltd.