Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
mepivacaine hydrochloride, Quantity: 20 mg/mL; adrenaline (epinephrine), Quantity: 0.01 mg/mL
Specialites Septodont Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium chloride; potassium metabisulfite; disodium edetate; hydrochloric acid; sodium hydroxide
Infiltration
50x1.8mL
(S4) Prescription Only Medicine
INDICATIONS AS AT MAY 2003: Scandonest 2% Special is recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.
Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-07-13
SCANDONEST 2% SPECIAL (WITH ADRENALINE). SCANDONEST 3% (WITHOUT VASOCONSTRICTOR (PLAIN)). CONSUMER MEDICINE INFORMATION WHAT’S IN YOUR MEDICINE SCANDONEST contains a local anaesthetic, Mepivacaine hydrochloride. Two different formulations of SCANDONEST are available. One formulation contains a vasoconstrictor called adrenaline. SCANDONEST 2% SPECIAL (WITH ADRENALINE) ACTIVE INGREDIENTS Cartridge 2.2 mL Cartridge 1.8 mL Mepivacaine hydrochloride 44 mg 36 mg Adrenaline 22 µg 18 µg OTHER INGREDIENTS: Sodium chloride, disodium edetate, potassium metabisulfite, hydrochloric acid, sodium hydroxide solution, water for injections. SCANDONEST 3% (WITHOUT VASOCONSTRICTOR (PLAIN)). ACTIVE INGREDIENTS Cartridge 2.2 mL Cartridge 1.8 mL Mepivacaine hydrochloride 66 mg 54 mg OTHER INGREDIENTS: Sodium chloride, Sodium hydroxide solution, water for injections. PRESENTATION FOR BOTH PRODUCTS: Box of 50 cartridges for single use, containing each 2.2 mL or 1.8 mL of solution. WHAT YOUR MEDICINE IS USED FOR AND HOW IT WORKS SCANDONEST 3% contains one active ingredient, Mepivacaine hydrochloride, a local anaesthetic to prevent the pain and is given by injection to cause loss of feeling before and during dental procedures. SCANDONEST 2% SPECIAL contains two active ingredients, Mepivacaine hydrochloride, a local anaesthetic to prevent the pain, and adrenaline, a vasoconstrictor, which makes the local anaesthetic action of Mepivacaine last longer (Adrenaline narrows the blood vessels at the site of injection, which keeps the anaesthetic where it’s needed for a longer time) and controls bleeding during the surgery. Your dentist will decide which SCANDONEST product (with or without adrenaline) is best for the procedure. 1 ADVICE BEFORE USING THE MEDICINAL PRODUCT In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your dentist will make before treatment. THIS PRODUCT SHOULD NOT BE USED IF ANY OF THE FOLLOWING APPLY TO YOU: - You are allergic to adrenal Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – SCANDONEST 2% SPECIAL (MEPIVACAINE HYDROCHLORIDE, ADRENALINE (EPINEPHRINE)) INJECTION 1 NAME OF THE MEDICINE Mepivacaine hydrochloride with adrenaline (epinephrine) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SCANDONEST 2% SPECIAL CARTRIDGE 2.2 ML CARTRIDGE 1.8 ML ACTIVE INGREDIENTS Mepivacaine hydrochloride 44 mg 36 mg Adrenaline (epinephrine) 22 µg 18 µg OTHER INGREDIENTS Sodium chloride 14.3 mg 11.7 mg Potassium metabisulfite 2.64 mg 2.16 mg Disodium edetate 0.55 mg 0.45 mg Sodium hydroxide solution (for pH adjustment) (for pH adjustment) Hydrochloric acid (for pH adjustment) (for pH adjustment) Water for injections q.s. 2.2 mL 1.8 mL Contains no anti-microbial agent. Mepivacaine hydrochloride is a local anaesthetic. Adrenaline (epinephrine) is a vasoconstrictor. Contains mepivacaine hydrochloride 2% (20 mg/mL) with adrenaline (epinephrine) 1:100,000 3 PHARMACEUTICAL FORM SCANDONEST 2% SPECIAL is a sterile aqueous injection, solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS SCANDONEST 2% SPECIAL is recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis. 2 4.2 D OSE AND METHOD OF ADMINISTRATION One or more cartridges should be used on a single patient on one occasion only during each session of treatment. If only a portion of a cartridge is used, the remainder must be discarded. 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. Toxic doses vary widely between patients and toxic effects may occur after any local anaesthetic procedure. Careful observation of the patient must be maintained after administration of the local anaesthetic. The product is injected either locally or in the vicinity of a dental nervous trunk. The safe dose for people with acute or chronic disease may be substantially less than that for healthy individuals. _Adults Read the complete document