Croma Saypha Lips 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® Lips with lidocaine is the variant of the Croma-Pharma range formulated specifically for lip augmentation. It shares with Saypha Filler the concentration of 23 mg/ml and the lowest degree of cross-linking in the range (0.5–1.0 %) —the softest and most mouldable gel— but its indication and its treatment plane are different: it is injected into the labial submucosa.
- 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 %. A minimally cross-linked gel deforms with the movement of the lip instead of resisting it, which is decisive in an area of constant animation.
- Lidocaine: 0.3 % (3 mg/ml). Relevant in the lips, one of the areas of the face with the highest density of nerve endings.
- 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 implant indicated by the manufacturer for lip augmentation.
- Body of the upper and lower lip
- Definition of the vermilion border and of the Cupid's bow
- Correction of lip asymmetries
Technique and treatment protocol
- Injection plane: labial submucosa.
- Needles included: 2 × 27G ½" thin wall Terumo™.
- Technique: linear retrograde along the vermilion or microdeposits in the body of the lip, with slow injection and subsequent moulding.
- Anticipate the usual post-treatment swelling of the lip area and adjust the volume accordingly.
- Never inject intravascularly. Pay particular attention to the course of the superior and inferior labial arteries.
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 | Labial submucosa |
| 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; 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 area, including active labial herpes; pregnancy and breastfeeding; under 18 years of age.
Caution: history of recurrent labial herpes (consider antiviral prophylaxis); anticoagulant or antiplatelet therapy; 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.