SCANDONEST 2% Special 1.8ml is a Prescription Medicines only administered by a dentist. Scandonest 2% Special : Mepivacaine hydrochloride 2% (20mg/mL) with adrenaline 1:100,000, Injection Solution. SCANDONEST 2% Special is recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.
CONTRAINDICATIONS: These include : a) contraindications to Mepivacaine (SCANDONEST 2% Special) : - specific allergies to Mepivacaine or to other anaesthetics of amide type, - allergies of cross type Procaine – Mepivacaine. b) contraindications to Adrenaline (SCANDONEST 2% Special) : - cerebral arteriosclerosis, - arterial hypertension, -coronary disease,- valvular cardiac disease (particularly sequelae to acute rheumatic fever). - thyrotoxicosis, untreated, - known sensitivity to sympathomimetic amines. c) hypersensitivity to sulfites (potassium metabisulfite is present in SCANDONEST 2% Special formula as an antioxidant), d) injection by intravenous route is strictly contra-indicated e) inflammation or sepsis in the region of the proposed injection f) hypersensitivity to any other component of SCANDONEST 2% Special g) patients receiving monoamine oxidase inhibitors (or who have received such an agent within two weeks) or tricyclic antidepressants.
Special warnings and precautions for use: General precautions:- WHEN ANY LOCAL ANAESTHETIC AGENT IS USED, RESUSCITATIVE EQUIPMENT AND DRUGS, INCLUDING OXYGEN, SHOULD BE IMMEDIATELY AVAILABLE IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS INVOLVING THE CARDIOVASCULAR, RESPIRATORY OR CENTRAL NERVOUS SYSTEMS. BECAUSE OF THE POSSIBILITY OF HYPOTENSION AND BRADYCARDIA FOLLOWING MAJOR BLOCKS, AN IV CANNULA SHOULD BE INSERTED BEFORE THE LOCAL ANAESTHETIC IS INJECTED. DELAY IN PROPER
MANAGEMENT OF DOSE-RELATED TOXICITY, UNDER VENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND DEATH.
- INJECTION SHOULD ALWAYS BE MADE SLOWLY WITH FREQUENT ASPIRATIONS TO AVOID INADVERTENT INTRAVASCULAR INJECTION, WHICH CAN PRODUCE CEREBRAL SYMPTOMS EVEN AT LOW DOSES.- Note, that the absence of blood in the syringe does not assure that intravascular injection will be avoided. There should be careful monitoring of cardiovascular and respiratory vital signs after each injection.
- Intra-vascular injection is strictly contra-indicated. An accidental injection into a blood vessel may be associated with systemic adverse effects due to the circulating levels of adrenaline and mepivacaine. Therefore, it is imperative to ensure that the needle being used for the injection does not go into a vessel.
- Since amide-type local anaesthetics are also metabolised by the liver and excreted via kidneys, SCANDONEST 2% Special should be used with caution in patients with hepatic or renal disease.
- Due to the presence of adrenaline, the product is not advised for diabetic subjects or for patients with thyrotoxicosis. Many drugs used during the conduct of anaesthesia are considered potential triggering agents for familial malignant hyperthermia, since it is not known whether amide-type local anaesthetics may trigger this reaction, and since the need for supplemental general anaesthesia cannot be predicted in advance, it is suggested that a standard protocol for management should be available.
Interaction with other medicines and other forms of interaction: The administration of local anaesthetic solutions containing adrenaline to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension. As SCANDONEST 2% Special contains a vasoconstrictor (adrenaline), concurrent treatment with a Beta-adrenergic blocking agent (propranolol, timolol, etc.) may result in dose-dependent hypertension and bradycardia with possible heart block. The effects of adrenaline may be potentiated by thyroid hormones.
Fertility, pregnancy and lactation: Use in pregnancy (Category A) – Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.): The safe use of Mepivacaine during pregnancy has not been established. Mepivacaine has however been used extensively for dental procedure during pregnancy with no proven increase in frequency of malformations or of harmful effects to mother or foetus. Adrenaline has been administered to a large number of pregnant women and women of child bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Use in lactation : It is not known whether mepivacaine or its metabolites appear in breast milk. Adrenaline is excreted in the breast milk. Therefore the use of SCANDONEST 2% Special is not recommended during lactation.
Dose:
The lowest dosage that results in effective anaesthesia for the planned treatment should be used. The dosage will depend upon the area of the oral cavity to be anaesthetised, the vascularity of the oral tissues and the technique of anaesthesia
Adults : a single cartridge (2.2 mL) is generally sufficient. Do not exceed three cartridges (6.6 mL)
Adolescents between 14 and 17 years : usual dosage one cartridge (2.2 mL). Do not exceed 2 cartridges (4.4 mL) in general cases.
Children between 6 and 14 years : usual dose is 1.35 mL. Do not exceed 2.7 mL in usual cases.
Children between 3 and 6 years : do not exceed maximum recommended dose of 1.8 mL.
Do not use on children under three years of age.
Undesirable effects: Common reactions (≥ 1% and <10%) : Excluding post procedural dental pain, local reactions at the injection site are the most common adverse events: infection, gingivitis, pain and oedema. Headache, paresthesia and hyperaesthesia are also reported after use of anaesthetic injections during dental procedures.
For full information on dosage, contraindications, precautions, interactions and adverse effects please refer to the data sheet available at www.medsafe.govt.nz or by clicking on the link provided with this product. NZ Sponsor: IVOCLAR VIVADENT Ltd, AUCKLAND, NEW ZEALAND
NP21450 - Aug 2024