Croma Saypha Filler Lidocaine 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® Filler with lidocaine is the cross-linked hyaluronic acid filler from Croma-Pharma indicated for the correction of moderate nasolabial folds. With 23 mg/ml of HA and a degree of cross-linking of 0.5–1.0 %, it is the least firm gel of the injectable Saypha range: it is designed to work in the mid to deep dermis, not to provide structural volume.
- Cross-linked HA 23 mg/ml
- Cross-linking 0.5–1.0 %
- Lidocaine 0.3 %
- 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: 0.5–1.0 %. This is the lowest value in the cross-linked Saypha range and defines the positioning of the product: a soft gel, easy to mould, for the correction of lines and not for projection.
- Lidocaine: 0.3 % (3 mg/ml), incorporated into the gel to reduce discomfort during injection.
- Manufacturing: in-house production by Croma-Pharma in Leobendorf (Austria), with a 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 moderate nasolabial folds.
- Moderate nasolabial folds
- Perioral lines and lines of the lower third of moderate intensity
For severe wrinkles or for volumetric restoration of the midface, the range provides Saypha Volume and Saypha Volume Plus respectively.
Technique and treatment protocol
- Injection plane: mid to deep dermis.
- Needles included: 2 × 27G ½" thin wall Terumo™, which reduce the extrusion force required.
- Technique: linear retrograde, fanning or cross-hatching, according to the morphology of the fold.
- Duration: in the clinical study of the Saypha range in nasolabial folds the correction was maintained for up to 9 months.
- Inject slowly and retrograde. Do not 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 | 0.5–1.0 % |
| Anaesthetic | Lidocaine 0.3 % |
| Presentation | 1 pre-filled syringe of 1.0 ml |
| Needles | 2 × 27G ½" thin wall Terumo™ |
| Treatment plane | Mid to deep dermis |
| 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 for the patient record.
Contraindications and warnings
Contraindications: known hypersensitivity to hyaluronic acid or to Gram-positive bacterial proteins; allergy to lidocaine or to amide-type local anaesthetics; porphyria; 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 previously treated 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.