Scandonest® 3% Plain Glass Cartridge 2.2 ml
Scandonest®
Prescription-only local anaesthetic medicine (POM)Mepivacaine hydrochloride 3% solution for injection (dental/locoregional anaesthesia) \u2014 glass cartridge
Certifications
- Holder of marketing authorisations across multiple jurisdictions (EU/EEA/UK/other national registrations); product information, SmPC and PIL available from manufacturer Septodont and national medicines agencies (e.g., EMA referral documentation, HPRA, TGA, national product databases).
- Manufactured and released under appropriate pharmaceutical quality and sterility procedures (terminal sterilisation stated in manufacturer literature).
- Holder of marketing authorisations across multiple jurisdictions (EU/EEA/UK/other national registrations); product information, SmPC and PIL available from manufacturer Septodont and national medicines agencies (e.g., EMA referral documentation, HPRA, TGA, national product databases).
- Manufactured and released under appropriate pharmaceutical quality and sterility procedures (terminal sterilisation stated in manufacturer literature).
Mepivacaine hydrochloride 3% solution for injection (dental/locoregional anaesthesia) \u2014 glass cartridge
Description
Scandonest® 3% Plain is a sterile, colourless solution of mepivacaine hydrochloride 30 mg/ml (3% w/v) supplied in glass cartridges (2.2 ml in the specified presentation). It is a local and loco-regional anaesthetic indicated primarily for dental surgery and certain minor surgical procedures (including chiropody). The formulation contains no vasoconstrictor (plain), no methylparaben and is terminally sterilised; components such as plungers/seals are latex-free. Cartridges are for single use only and intended for use by appropriately trained healthcare professionals.
Bnefits
- Rapid onset of anaesthesia (often within 30 seconds to a few minutes depending on site).
- Operative/pulpal anaesthesia duration typically ~20–40 minutes (varies by site; dental guidelines).
- Plain formulation (no vasoconstrictor) suitable for situations where a vasoconstrictor is contraindicated.
- No-methylparaben formulation and latex-free components to reduce certain allergy risks.
- Terminal sterilisation and single-use cartridges for safety and infection control.
Indications
- Local and loco-regional anaesthesia in dental surgery (adults, adolescents and children above approximately 4 years / ~20 kg body weight).
- Chiropody and other minor surgical procedures where a short-acting plain local anaesthetic is appropriate.
- Infiltration and perineural use as indicated in the product literature (use immediately after opening; single use).
Composition
- Active substance: mepivacaine hydrochloride 30 mg per ml (3% w/v) — each 2.2 ml cartridge contains 66 mg mepivacaine hydrochloride.
- Excipients with known effect: sodium chloride; sodium hydroxide (or hydrochloric acid) to adjust pH; water for injection.
- No methylparaben; cartridge components specified as latex-free in manufacturer literature.
Formulation
- Clear, colourless sterile solution for injection (2.2 ml glass cartridge presentation specified).
- Packed in glass cartridges with elastomeric stopper and aluminium cap; cartridges intended for use with compatible dental syringe systems.
- Single-use cartridges; do not autoclave; use immediately after opening.
Packaging
- Pack presentations marketed include boxes of cartridges (common commercial presentations: 50 x 2.2 ml cartridges / 5 x 10 x 2.2 ml cartridges depending on market).
- Each cartridge is sealed; outer carton labelled with product name, strength, batch/lot number, expiry date and manufacturer/MAH details as per regulatory requirements.
Usage
- For administration by or under the supervision of clinicians trained in local anaesthesia and management of systemic toxicity; follow local guidelines and the product leaflet/SmPC.
- Routes: infiltration and perineural administration as described in the SmPC/IFU.
- Observe aseptic technique, do not use if solution is cloudy or discoloured, discard unused solution; the rate of injection should generally not exceed 1 ml per minute unless clinically indicated.
- Ensure availability of appropriate resuscitation equipment and trained staff when administering local anaesthetics.
Contraindications
- Known hypersensitivity to mepivacaine hydrochloride or to any excipient in the product.
- Situations with a known severe reaction to local anaesthetics of the amide group unless judged appropriate by clinician with precautions.
- Use caution or avoid in patients with severe hepatic disease or conditions predisposing to accumulation (dose adjustment/monitoring may be required).
Adverse Effects
- Common/expected local transient effects: injection site pain, swelling, bruising, transient numbness.
- Less common/serious: systemic local anaesthetic toxicity (CNS effects such as drowsiness, dizziness, convulsions; cardiovascular effects including arrhythmias, hypotension) particularly with overdose or inadvertent intravascular injection.
- Rare: allergic reactions including anaphylaxis (excipients and cartridge components can rarely contribute).
- Appropriate management of suspected systemic toxicity and vascular complications should be available.
Storage Conditions
- Store below 25°C, protect from light, do not freeze — follow specific storage and shelf-life details printed on the carton and SmPC/IFU for the marketed presentation.
- Discard any opened/partially used cartridges; follow local disposal regulations for medicinal waste.
Duration
Typical clinical/pulpal anaesthesia durations reported: about 20 minutes (maxilla) to 40 minutes (mandible) for common dental blocks; operative duration may vary with dose, site and patient factors. (Manufacturer/SmPC references provide typical ranges.)
Onset
Fast onset \u2014 typically 30 to 120 seconds in the maxilla and 1 to 4 minutes in the mandible for dental injections, with clinical variability by technique and site.
