GALAXY
PREMIUM FILLER

Galaxyis a sterile, transparent gel of cross-linked hyaluronic acid of non-animal origin hydrochloride. Galaxy is supplied in a glass syringe with a luer-lock fitting. The contents of the syringe have been sterilized using moist heat. Disposable sterile needles are provided with a syringe.
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COMPOSITION

Cross-linked hyaluronic acid 24 mg/mL
Syringes contains 10ml

Galaxyis intended to be used for facial tissue
augmentation.
Galaxy is used in the correction of folds of the face. It should be injected into the deep layer of the dermis and/or the surface layer of subcutis. The addition of lidocaine provides a pain-relieving effect during treatment.

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Do not use​

in patients with bleeding disorders or patients who have undergone therapy with thrombolytic anticoagulants, or inhibitors of platelet aggregation in the preceding 2 weeks. In the same way, it is recommended to avoid taking aspirin, non-steroidal anti-inflammatory drug or high does vitamin C the week before the injection.

Confirm that

The product has not be expired and that sterility has not been compromised before use, product is for single use only; do not re-use. In case of re-use, this can cause to depress performance of the device and may lead to severe cross-infection. Used needles and syringes must be disposed into a collector designed for this purpose.

Patients should be recommended not to apply make-up for 12 hours after injection and to avoid prolonged exposure to sunlight, UV, as well as extreme cold and heat for two weeks after the injection.

  • Galaxy should not be mixed with other products before implantation of the device.
  • If the needle is blocked, do not increase the pressure on the plunger rod but the stop the injection and replace the needle.
  • Galaxy is only intended for used as an intradermal and/or subcutaneous implant
  • Galaxy should not be injected into an area where there is an implant.
  • Do not use if package is opened or damaged.
  • Galaxyis packaged for single patient use. Do not re-sterilize

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ADVERSE EVENTS

Physicians must inform patients that there are potential adverse event that may occur immediately or be delayed after the injection. These adverse events include but are not limited to:

– Inflammatory reactions such as redness, swelling and tenderness may occur at the injection site. These reactions may last for two weeks.

– Nodules or indurations are also possible at the injection site.

– Haematomas

– Staining or discoloration of the injection site

– Poor effect or weak filling effect.

– Cases of glabellar necrosis, abscess formation

Granuloma and immediate or delayed hypersensitivity have been reported in the literature following hyaluronic acid injection. It is therefore important to take such possible complications into account. Patients must report inflammatory reactions which persist for more than one week or any other secondary effect which develops to their practitioner as soon as possible. The practitioner should treat theses as appropriate.
Manufacturer : Beauty Revolution FZE

 GALAXY FILLER 
Address : Prastekæervej 7,3 tv2700 Bronshoj, Copenhagen, Denmark
www.galaxyfiller.com

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