Croma Saypha Volume 1x1ml
Important Notice
Regulated medical device (EU MDR 2017/745). For sale exclusively to qualified healthcare professionals.
What this purchase includes
- Original productFrom the manufacturer or an official distributor, CE marked.
- Batch and expiry documentedRecorded per unit on the delivery note and the invoice.
- Controlled storageOur own Madrid warehouse, 12 to 18 °C under 24 h control.
- Dispatch in 24 to 48 hFrom Madrid, insured and with a tracking number.
- Reachable Monday to Friday9:00 to 17:00 by WhatsApp and email. People, not forms.
Saypha® Volume is the cross-linked hyaluronic acid filler from Croma-Pharma for the correction of severe nasolabial folds, in its version without anaesthetic. It shares gel, concentration (23 mg/ml) and degree of cross-linking (0.5–1.5 %) with Saypha Volume with lidocaine; the only difference is the absence of lidocaine, which allows the anaesthetic protocol to be chosen freely (topical, nerve block or prior infiltration).
- Cross-linked HA 23 mg/ml
- Cross-linking 0.5–1.5 %
- Anaesthetic without lidocaine
- Contents 1 syringe × 1 ml
- Needles 2 × 27G ½"
Composition and technology
- Cross-linked hyaluronic acid: 23 mg/ml, of non-animal origin obtained by bacterial fermentation.
- Degree of cross-linking: 0.5–1.5 %, higher than that of Saypha Filler. At the same HA concentration, a higher cross-linking density increases the gel's resistance to deformation and its persistence in deep planes.
- Without anaesthetic: lidocaine-free formulation. Indicated where there is allergy or intolerance to amide-type local anaesthetics, or when the practitioner prefers to manage anaesthesia separately.
- Manufacturing: in-house production by Croma-Pharma in Leobendorf (Austria), pre-filled syringe sterilised by moist heat.
Differences between the Saypha variants
| Saypha Filler (± lidocaine) | HA 23 mg/ml, cross-linking 0.5–1.0 % — moderate nasolabial folds, mid to deep dermis |
|---|---|
| Saypha Volume (± lidocaine) | HA 23 mg/ml, cross-linking 0.5–1.5 % — severe nasolabial folds, deep dermis and subcutis |
| Saypha Volume Plus lidocaine | HA 25 mg/ml, cross-linking 1.0–2.0 % — volume deficit of the midface, deep subcutaneous or supraperiosteal plane |
| Saypha Lips lidocaine | HA 23 mg/ml, cross-linking 0.5–1.0 % — lip augmentation, submucosa |
| Saypha Rich | Non-cross-linked HA 18 mg/ml + glycerol — skin revitalisation in the superficial dermis. It is not a volumising filler |
Indications and treatment areas
Injectable hyaluronic acid implant indicated by the manufacturer for the correction of severe nasolabial folds.
- Severe nasolabial folds
- Deep folds of the lower facial third
For volume deficit of the midface, the range provides Saypha Volume Plus, with a higher concentration and degree of cross-linking.
Technique and treatment protocol
- Injection plane: deep dermis and subcutaneous tissue.
- Needles included: 2 × 27G ½" thin wall Terumo™.
- Anaesthesia: as it does not contain lidocaine, prior topical anaesthesia or nerve block is recommended according to the area and the patient's sensitivity.
- Technique: linear retrograde or fanning, with slow injection and prior aspiration according to clinical protocol.
- Duration: in the clinical study of the Saypha range in nasolabial folds the correction was maintained for up to 9 months.
- Never inject intravascularly. Do not apply over areas with permanent implants.
Technical data
| Manufacturer | Croma-Pharma GmbH, Leobendorf, Austria |
|---|---|
| Active substance | Cross-linked hyaluronic acid 23 mg/ml, non-animal origin |
| Degree of cross-linking | 0.5–1.5 % |
| Anaesthetic | Not contained |
| Presentation | 1 pre-filled syringe of 1.0 ml |
| Needles | 2 × 27G ½" thin wall Terumo™ |
| Treatment plane | Deep dermis, subcutis |
| Classification | Class III medical device, CE mark 0123 (MDR 2017/745) |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 2 °C and 25 °C, protected from direct sunlight. Do not freeze.
- Do not use after the expiry date stated on the pack.
- Single-use product. Do not reuse or re-sterilise.
- The pack contains: 1 pre-filled syringe of 1.0 ml, 2 needles 27G ½", instructions for use and traceability labels.
Contraindications and warnings
Contraindications: known hypersensitivity to hyaluronic acid or to Gram-positive bacterial proteins; active autoimmune disease; tendency to hypertrophic or keloid scarring; active skin infection or inflammation in the treatment area; pregnancy and breastfeeding; under 18 years of age.
Caution: anticoagulant or antiplatelet therapy; history of severe allergic reactions; areas with permanent implants. Do not combine in the same session with laser, deep peeling or dermabrasion.
Always consult the instructions for use included in the pack before treatment.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official documentation of Croma-Pharma (Saypha portfolio brochure). This information sheet does not replace the instructions for use supplied with the product.