Belotero VOLUME – 2 syringes of 1 ml

189,90 (VAT included)


Belotero VOLUME. The patient is recommended to report to their doctor the onset of any side effect that lasts more than a week.

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Belotero VOLUME – 2 syringes of 1 ml

The patient is recommended to report to their doctor the onset of any side effect that lasts more than a week. In fact, the doctor will be able to prescribe adequate treatment to the patient. Assembling the needle in the syringe For optimal use of the product, it is important that the needle is correctly inserted into the syringe. See diagrams 1, 2, 3 and 4. 1. Firmly hold the glass barrel of the syringe and the luer adapter – lock between thumb and forefinger. 2. With the other hand, grab the protective cap and unscrew it. 3. Push and rotate the needle on the syringe to the latch. Do not overtighten to prevent the luer-lock from moving and detaching from the syringe. 4. Continuing to hold the luer-lock, remove the sheath from the needle. Storage Store at a temperature between 2°C and 30°C. Protect from light and frost. Avoid bumps. Cross-linked sodium hyaluronate gel of sterile non-animal origin, pyrogen-inducing, viscoelastic, colorless, transparent, in a saline phosphate buffer. Presentation The product comes in a disposable prefilled glass syringe, sterilized with wet heat in an autoclave. Each package contains 2 product syringes, 1 sterile needle 30G 0.5 Inch and 1 sterile needle 27G 0.5, 1 sterile cannula 27 G/37 mm, 1 package leaflet and 4 traceability labels. CE marked sterile needles are disposable. Composition Cross-linked sodium hyaluronate 26 mg Phosphate buffer pH 7 q. s. As reported on the syringe label and on the box. The volume of gel contained in each syringe is shown on the syringe label and on the box. The product is an injectable and absorbable implant, indicated for the restoration of facial volumes, for example to increase the volume of the cheekbones or chin. Dosage and method of administration The product should be used for injections into the deep dermis, subcutaneously or into the outermost periosteum, by a doctor duly qualified to carry out this procedure. For the success of the treatment it is essential that the doctor has received specific training on injection techniques for the restoration of facial volume. It is necessary to have a good knowledge of the anatomy and physiology of the site to be treated. Treatment should be performed under conditions of adequate asepsis. The product should be injected into healthy, non-inflamed skin and thoroughly disinfected previously. It is recommended to use one of the needles provided in the package. However, it is possible to use other sterile needles or cannulas that can be adapted for the correct connection to the luer-lock connector of the syringe, depending on the injection technique adopted or the preferences of the doctor. In this case you can use a needle or cannula recommended by Merz, with a diameter of 18 G to 30 G. For optimal use of the product it is recommended to carry out needle assembly as shown in the diagrams below. If the needle becomes clogged and the injection pressure becomes excessive, suspend the procedure and change the needle or cannula. If necessary, a local or loco anesthetic can be used – regional. In this case, you must adhere to the instructions for use of these products. The amount of gel to be injected depends on the area that needs to be treated. It is recommended not to inject, in one session, more than 3 ml for each treatment site. Do not overcorregger. After injection, perform a light massage on the treated area, for even distribution of the product. Cons The product is contraindicated in the following cases: • known hypersensitivity to one or more of the components of the product, in particular to sodium hyaluronate; • in pregnant and/or breastfeeding women; • in young people under the age of 18; • in patients who have a general infection. Do not inject the product into the blood vessels. Do not inject the product into the region. Do not inject the product into the region of the nose grooves – jugals. Do not inject the product into the lips. Do not inject the product into areas that have skin problems of an inflammatory or infectious nature (acne, herpes, etc.). Do not inject the product for the correction of superficial wrinkles and fine wrinkles (injection of the product into the superficial dermis). Do not inject the product into an area previously treated with permanent dermal filler. Precautions of use Before treatment, the patient should receive adequate information about the device, cons and any side effects. In the absence of clinical data on the tolerability and efficacy of injections of the product in patients with previous or ongoing autoimmune disease, the doctor should decide on a case-by-case basis, depending on the nature of the disease and the treatment received, whether to proceed with the injection of the product. It is recommended to propose to these patients to undergo a double preliminary test and not to inject the product if the disease is progressing. It is also recommended to carefully monitor these patients after injection. The product can be used to correct signs caused by the loss of facial adipose tissue (lipoatrophy) in patients with human immunodeficiency virus. It is recommended not to inject the product into patients with a history of streptococcal infections and in patients predisposed to hypertrophic or keloid scars. It is recommended not to inject the product into the periorbital region. The product should not be used in combination with other aesthetic medicine techniques such as peeling, dermoabrasion or any other type of laser treatment, before the complete healing of the last treatment. In any case, even if healing is achieved earlier than expected, the product should not be used earlier than 2 weeks after the last treatment. No clinical data are available on the combined use of the product with the treatments mentioned above. No clinical data are available on the injection of the product into an area already treated with another filler product. Before use, check the integrity of the inner packaging and the expiration date of both the syringe and the needle. Do not use these products after the expiration date or if the packaging is open or damaged. At the discretion of the doctor, a local or loco anesthetic may be used – regional. Keep in mind that the anesthetic can cause localized redness and hypersensitivity. Patients taking anticoagulant substances, such as aspirin or nonsteroidal anti-inflammatory drugs, are more likely to develop reactions such as hematomas, nodules or bleeding at the injection site. Do not transfer the product to another container and do not add other ingredients to the product. Only the gel, and not the outer surface of the syringe, is sterile. The product should not be used with an automatic injection device not recommended by Merz. If you use an automatic device, it is recommended that the doctor has previously read the instructions for use of the injection device and is trained in its use. After use, throw the syringe and the residual product. Do not resterilize and reuse, because of the risks associated with such practices, including infections. The patient should avoid applying makeup for at least 12 hours after treatment and should avoid saunas and steam rooms as well as prolonged exposure to the sun or UV rays for 2 weeks after treatment. Patients should also avoid exerting pressure and/or manipulating the treated area of the face. Incompatibility Sodium hyaluronate precipitates in the presence of quaternary ammonium salts (such as benzalkonium chloride). It is therefore advisable that the product does not come into contact with these substances. Side effects Since side effects may occur, the doctor should inform the patient about it, before treatment. During the injection, slight bleeding may occur, which should still disappear spontaneously at the end of the injection. In some cases, immediately after the injection or as a late reaction, one or more of the following reactions may occur (non-exhaustive list): • reactions usually associated with the injection such as redness, erythema, edema or pain, sometimes accompanied by itching in the treated area. These reactions can last a week; – hematomas in the treated area; – swelling in the treated area; – hardening or nodules in the treated area; – changes in skin color in the treated area; – allergy to one or more components of the product, in particular to sodium hyaluronate; – cases of necrosis, abscesses and granulomas after sodium hyaluronate injections have been reported in the literature. These potential risks, although rare, must be taken into account.



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Weight0.3 kg


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