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SKU 11052 · GTIN 4046222013455

Radiesse

Dostępny
Objętość
1 x 1.5mL
Laboratorium
Merz Aesthetics
Pochodzenie
Stany Zjednoczone
Wskazanie
Moderate to deep facial folds, facial volume loss
Cena hurtowa i historia tylko dla zweryfikowanych
allpara zaopatruje licencjonowanych specjalistów. Zaloguj się lub załóż konto B2B, aby zobaczyć aktualne ceny, progi ilościowe i historię cen.

Radiesse is a sterile, latex-free, non-pyrogenic, semi-solid cohesive injectable implant manufactured by Merz Aesthetics, designed for deep dermal and sub-dermal soft tissue augmentation with a 27G needle. Its gel carrier dissipates in vivo, replaced by soft tissue growth, while the calcium hydroxylapatite stays in place, for long-term but non-permanent restoration and augmentation. By weight it is 56% synthetic CaHA particles (25 to 45 microns) and 44% carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. One pre-filled 1.5 mL syringe and two 27G thin-wall needles come sterile in a sealed foil pouch, for single person, single treatment use.

Najważniejsze zalety: Radiesse

  • Synthetic calcium hydroxylapatite implant, a different product class from a hyaluronic acid filler
  • 56% CaHA particles and 44% gel carrier by weight, with a particle size of 25 to 45 microns
  • The gel carrier is dissipated in vivo and replaced with soft tissue growth, while the CaHA remains at the injection site
  • A lifetime of at least 12 months across every approved indication, as a demonstrated minimum rather than an expected end point
  • Highly viscoelastic, well suited to sub-dermal and deep dermal placement for a considerable volumising effect
  • Can be diluted 1:2 with sterile saline for larger areas such as the décolleté
  • Supplied sterile in a sealed foil pouch as one 1.5 mL syringe with two 27G thin-wall needles
  • CE marked under EU MDR 2017/745 via notified body 0123, supplied with a patient Implant Card
  • Manufactured by Merz Aesthetics in the USA
Najważniejsze informacje
Marka RADIESSE
Producent Merz Aesthetics
Kraj pochodzenia United States
Certyfikacja CE marked in accordance with Regulation (EU) 2017/745. Supplied with a patient Implant Card. Basic UDI-DI 018629500DF30001LK; the Summary of Safety and Clinical Performance is available via EUDAMED at ec.europa.eu/tools/eudamed
Skład Synthetic calcium hydroxylapatite (CaHA) particles, 25-45 microns, suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. By weight 56% CaHA particles and 44% gel carrier, the gel comprising 36.0% sterile water for injection, 6.6% glycerin and 1.4% sodium carboxymethylcellulose. Non-animal-based and free from animal protein
Objętość / Rozmiar 1.5 ml
Opakowanie One pre-filled 1.5 mL syringe with a Terumo K-Pack II containing two 27G thin-wall injection needles, supplied sterile in a sealed foil pouch. Single person, single treatment use
Rozmiar igły 27G thin-wall needle with a standard Luer fitting; two needles supplied in the pack
Rodzaj zastosowania For professional use - qualified practitioners and clinics only
Głębokość iniekcji Deep dermal and sub-dermal soft tissue augmentation. Highly viscoelastic CaHA is well suited to sub-dermal and deep dermal placement
Protokół / Czas trwania A lifetime of at least a year or more in most persons, with at least 12 months for every approved indication: nasolabial folds, cheek augmentation, hand augmentation, facial fat loss in people with HIV, and moderate to severe decollete wrinkles. These are minimum persistence figures demonstrated in clinical follow-up rather than expected end points. Duration varies with the patient, the area treated, the volume placed and the injection technique

Wskazania i zastosowanie profesjonalne

Główne wskazania

  • Treatment of nasolabial folds
  • Augmentation of the cheeks
  • Hand augmentation to correct volume loss in the dorsum of the hands
  • Restoration and correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus
  • Moderate and severe décolleté wrinkles, when diluted 1:2 with 0.9% sterile saline

Zastosowanie profesjonalne

Radiesse is only to be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law. The product is supplied sterile and non-pyrogenic in a sealed foil pouch and is intended for single-person, single-treatment use only, for deep dermal and sub-dermal soft tissue augmentation. Injection technique, plane and volume are determined by the treating practitioner on a per-patient basis. Introduction of the implant into the vasculature may lead to embolisation or thrombosis, occlusion of the vessels, ischaemia or infarction, so particular care is required when injecting soft tissue fillers. The product must not be re-sterilised, and must not be used if the foil pouch is compromised or the syringe damaged.

Obszary zabiegowe

  • Nasolabial folds
  • Cheeks
  • Dorsum of the hands
  • Areas of facial fat loss (lipoatrophy) in people with HIV
  • Décolleté, when diluted 1:2 with 0.9% sterile saline
  • Not intended for the glabellar folds or the nose area, where a higher incidence of localised necrosis has been associated with injection

Profil pacjenta

Suitable for adult patients assessed as appropriate by the treating practitioner. Radiesse is contraindicated in the presence of acute or chronic inflammation or infection involving the area to be treated; in persons with severe allergies manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies; in persons with known hypersensitivity to any of the components; in persons prone to developing inflammatory skin conditions or with a tendency to develop hypertrophic scars and keloids; in persons with bleeding disorders; and during pregnancy and in breastfeeding females. It must not be implanted in the epidermis or used as a skin replacement, and is not intended for correction of the glabellar folds or the nose area. For hand augmentation, the safety of injection into the dorsum of the hand has not been studied in persons under 26 or over 79 years of age, volumes over 3 mL per hand in a treatment session have not been studied, and safety beyond one year in the hand has not been investigated in clinical trials.

Jak działa Radiesse ​

Radiesse is composed of synthetic calcium hydroxylapatite microspheres, 25 to 45 microns in size, suspended in a gel carrier of sterile water, glycerin and sodium carboxymethylcellulose. The gel carrier is dissipated in vivo and replaced with soft tissue growth, while the calcium hydroxylapatite remains at the site of injection, producing a long-term yet non-permanent restoration and augmentation. Highly viscoelastic CaHA is well suited to sub-dermal and deep dermal placement, where it delivers a considerable volumising effect. Diluting the implant makes it less viscous and therefore more suitable for rejuvenation of larger areas such as the décolleté.

Dlaczego warto zamawiać w Allpara

Allpara oferuje oryginalne, sprawdzone produkty RADIESSE od zweryfikowanych dostawców, z pełną identyfikowalnością partii i wsparciem ekspertów. Obsługujemy kliniki i specjalistów medycyny estetycznej, oferując produkty z certyfikatem CE, szybką dostawę na terenie całej UE z naszego magazynu w UE oraz konkurencyjne ceny hurtowe. Najważniejsze są dla nas bezpieczeństwo, satysfakcja i efekty Twoich pacjentów - z dedykowanym wsparciem posprzedażowym dla Twojego spokoju.

Najczęściej zadawane pytania

How does Radiesse work?

The gel carrier is dissipated in vivo and replaced with soft tissue growth, while the calcium hydroxylapatite remains at the site of injection. The result is a long-term but non-permanent restoration and augmentation. Highly viscoelastic CaHA is well suited to sub-dermal and deep dermal placement and delivers a considerable volumising effect.

How long does Radiesse last?

Radiesse has a lifetime of at least a year or more in most persons, with at least 12 months across every approved indication: nasolabial folds, augmentation of the cheeks, hand augmentation, facial fat loss in people with HIV, and moderate to severe décolleté wrinkles. These are minimum persistence figures demonstrated in clinical follow-up rather than expected end points. Duration varies with the individual patient, the area treated, the volume placed and the injection technique used.

Więcej od Merz

Zobacz laboratorium

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Radiesse

Dostępny
Oznaczenie CE Oznaczenie CE Radiesse
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Zaloguj się lub załóż konto B2B, aby zobaczyć swoją cenę.
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Radiesse is a sterile, latex-free, non-pyrogenic, semi-solid cohesive injectable implant manufactured by Merz Aesthetics, designed for deep dermal and sub-dermal soft tissue augmentation with a 27G needle. Its gel carrier dissipates in vivo, replaced by soft tissue growth, while the calcium hydroxylapatite stays in place, for long-term but non-permanent restoration and augmentation. By weight it is 56% synthetic CaHA particles (25 to 45 microns) and 44% carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. One pre-filled 1.5 mL syringe and two 27G thin-wall needles come sterile in a sealed foil pouch, for single person, single treatment use.

Najważniejsze zalety: Radiesse

  • Synthetic calcium hydroxylapatite implant, a different product class from a hyaluronic acid filler
  • 56% CaHA particles and 44% gel carrier by weight, with a particle size of 25 to 45 microns
  • The gel carrier is dissipated in vivo and replaced with soft tissue growth, while the CaHA remains at the injection site
  • A lifetime of at least 12 months across every approved indication, as a demonstrated minimum rather than an expected end point
  • Highly viscoelastic, well suited to sub-dermal and deep dermal placement for a considerable volumising effect
  • Can be diluted 1:2 with sterile saline for larger areas such as the décolleté
  • Supplied sterile in a sealed foil pouch as one 1.5 mL syringe with two 27G thin-wall needles
  • CE marked under EU MDR 2017/745 via notified body 0123, supplied with a patient Implant Card
  • Manufactured by Merz Aesthetics in the USA
Najważniejsze informacje
Marka RADIESSE
Producent Merz Aesthetics
Kraj pochodzenia United States
Certyfikacja CE marked in accordance with Regulation (EU) 2017/745. Supplied with a patient Implant Card. Basic UDI-DI 018629500DF30001LK; the Summary of Safety and Clinical Performance is available via EUDAMED at ec.europa.eu/tools/eudamed
Skład Synthetic calcium hydroxylapatite (CaHA) particles, 25-45 microns, suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. By weight 56% CaHA particles and 44% gel carrier, the gel comprising 36.0% sterile water for injection, 6.6% glycerin and 1.4% sodium carboxymethylcellulose. Non-animal-based and free from animal protein
Objętość / Rozmiar 1.5 ml
Opakowanie One pre-filled 1.5 mL syringe with a Terumo K-Pack II containing two 27G thin-wall injection needles, supplied sterile in a sealed foil pouch. Single person, single treatment use
Rozmiar igły 27G thin-wall needle with a standard Luer fitting; two needles supplied in the pack
Rodzaj zastosowania For professional use - qualified practitioners and clinics only
Głębokość iniekcji Deep dermal and sub-dermal soft tissue augmentation. Highly viscoelastic CaHA is well suited to sub-dermal and deep dermal placement
Protokół / Czas trwania A lifetime of at least a year or more in most persons, with at least 12 months for every approved indication: nasolabial folds, cheek augmentation, hand augmentation, facial fat loss in people with HIV, and moderate to severe decollete wrinkles. These are minimum persistence figures demonstrated in clinical follow-up rather than expected end points. Duration varies with the patient, the area treated, the volume placed and the injection technique

Wskazania i zastosowanie profesjonalne

Główne wskazania

  • Treatment of nasolabial folds
  • Augmentation of the cheeks
  • Hand augmentation to correct volume loss in the dorsum of the hands
  • Restoration and correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus
  • Moderate and severe décolleté wrinkles, when diluted 1:2 with 0.9% sterile saline

Zastosowanie profesjonalne

Radiesse is only to be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law. The product is supplied sterile and non-pyrogenic in a sealed foil pouch and is intended for single-person, single-treatment use only, for deep dermal and sub-dermal soft tissue augmentation. Injection technique, plane and volume are determined by the treating practitioner on a per-patient basis. Introduction of the implant into the vasculature may lead to embolisation or thrombosis, occlusion of the vessels, ischaemia or infarction, so particular care is required when injecting soft tissue fillers. The product must not be re-sterilised, and must not be used if the foil pouch is compromised or the syringe damaged.

Obszary zabiegowe

  • Nasolabial folds
  • Cheeks
  • Dorsum of the hands
  • Areas of facial fat loss (lipoatrophy) in people with HIV
  • Décolleté, when diluted 1:2 with 0.9% sterile saline
  • Not intended for the glabellar folds or the nose area, where a higher incidence of localised necrosis has been associated with injection

Profil pacjenta

Suitable for adult patients assessed as appropriate by the treating practitioner. Radiesse is contraindicated in the presence of acute or chronic inflammation or infection involving the area to be treated; in persons with severe allergies manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies; in persons with known hypersensitivity to any of the components; in persons prone to developing inflammatory skin conditions or with a tendency to develop hypertrophic scars and keloids; in persons with bleeding disorders; and during pregnancy and in breastfeeding females. It must not be implanted in the epidermis or used as a skin replacement, and is not intended for correction of the glabellar folds or the nose area. For hand augmentation, the safety of injection into the dorsum of the hand has not been studied in persons under 26 or over 79 years of age, volumes over 3 mL per hand in a treatment session have not been studied, and safety beyond one year in the hand has not been investigated in clinical trials.

Jak działa Radiesse ​

Radiesse is composed of synthetic calcium hydroxylapatite microspheres, 25 to 45 microns in size, suspended in a gel carrier of sterile water, glycerin and sodium carboxymethylcellulose. The gel carrier is dissipated in vivo and replaced with soft tissue growth, while the calcium hydroxylapatite remains at the site of injection, producing a long-term yet non-permanent restoration and augmentation. Highly viscoelastic CaHA is well suited to sub-dermal and deep dermal placement, where it delivers a considerable volumising effect. Diluting the implant makes it less viscous and therefore more suitable for rejuvenation of larger areas such as the décolleté.

Dlaczego warto zamawiać w Allpara

Allpara oferuje oryginalne, sprawdzone produkty RADIESSE z pełną identyfikowalnością partii, produktami z certyfikatem CE, szybką dostawą na terenie całej UE i fachowym wsparciem posprzedażowym.

Najczęściej zadawane pytania

How does Radiesse work?

The gel carrier is dissipated in vivo and replaced with soft tissue growth, while the calcium hydroxylapatite remains at the site of injection. The result is a long-term but non-permanent restoration and augmentation. Highly viscoelastic CaHA is well suited to sub-dermal and deep dermal placement and delivers a considerable volumising effect.

How long does Radiesse last?

Radiesse has a lifetime of at least a year or more in most persons, with at least 12 months across every approved indication: nasolabial folds, augmentation of the cheeks, hand augmentation, facial fat loss in people with HIV, and moderate to severe décolleté wrinkles. These are minimum persistence figures demonstrated in clinical follow-up rather than expected end points. Duration varies with the individual patient, the area treated, the volume placed and the injection technique used.

Więcej od Merz

Zobacz laboratorium →
* Produkt do użytku profesjonalnego. Opakowanie może się różnić w zależności od partii lub rynku. Pełne zalecenia i przeciwwskazania znajdziesz w dołączonej instrukcji użycia (IFU).