SEPTANEST 1:100,000: articaine hydrochloride 4% with adrenaline (epinephrine) acid tartrate 1:100,000 [i.e. articaine hydrochloride 40 mg/mL with adrenaline (epinephrine) 10µg/mL] is a Prescription Medicine.
THERAPEUTIC INDICATIONS: SEPTANEST 1:100,000 is indicated for local or regional anaesthesia for both simple and complex dental procedures in adults, adolescents and children 4 years of age and older. SEPTANEST 1:100,000 is indicated only for dental procedures.
CONTRAINDICATIONS: Hypersensitivity to articaine (or any local anaesthetic agent of the amide type) or to adrenaline (epinephrine) or to any of the excipients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Before using SEPTANEST, it is important: - To make inquiries into the patient’s current therapies and history; - To maintain verbal contact with the patient.
WHEN ANY LOCAL ANAESTHETIC AGENT IS USED, RESUSCITATIVE EQUIPMENT AND RESUSCITATIVE DRUGS, INCLUDING OXYGEN, SHOULD BE IMMEDIATELY AVAILABLE IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS INVOLVING THE CARDIOVASCULAR, RESPIRATORY OR CENTRAL NERVOUS SYSTEMS. INJECTION SHOULD ALWAYS BE MADE SLOWLY WITH FREQUENT ASPIRATIONS TO AVOID INADVERTENT INTRAVASCULAR INJECTION, WHICH CAN PRODUCE CEREBRAL SYMPTOMS EVEN AT LOW DOSES.
Special Warnings: SEPTANEST must be used with caution in: Patients with cardiovascular disorders: Patients with epileptic disease, patients with plasma cholinesterase deficiency, patients with myasthenia gravis, patients receiving treatment with antiplatelets / anticoagulants, patients receiving treatment with Monoamine Oxidase Inhibitors (MAOis), patients with porphyria, patients with diabetes, patients with susceptibility of acute angle-closure glaucoma, patients with cerebrovascular insufficiency.
Precautions for use: Use in hepatic impairment- the lowest dose leading to efficient anaesthesia should be used. Use in renal impairment- the lowest dose leading to efficient anaesthesia should be used. Use in the elderly- in patients over 70 years old, the lowest dose leading to efficient anaesthesia should be used. Paediatric use- SEPTANEST should not be used in children younger than 4 years of age as safety and effectiveness have not been established in this age group.
INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS: See datasheet for full list.
FERTILITY, PREGNANCY AND LACTATION: Effects on fertility- No effects on male or female fertility were observed in rats given articaine hydrochloride with adrenaline (epinephrine) subcutaneously from prior to mating until mating (males) or early gestation (females) at doses up to 80 mg/kg/day (approximately twice the maximum recommended human dose on a mg/m² basis). Use in pregnancy – Pregnancy Category B3. Use in lactation. It is unknown whether articaine or adrenaline (epinephrine) is excreted in human breast milk. The excretion of articaine or adrenaline (epinephrine) in milk has not been studied in animals. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with SEPTANEST should be made taking into account the benefit of breast-feeding to the child and the benefit of SEPTANEST therapy to the woman. Nursing mothers are advised to express and discard breast milk for approximately 4 hours after administration of articaine.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The combination articaine hydrochloride with adrenaline (epinephrine) acid tartrate solution for injection may have minor influence on the ability to drive and use machines.
UNDESIRABLE EFFECTS: Adverse reactions following administration of articaine / adrenaline (epinephrine) are similar to those observed with other local amide anaesthetics / vasoconstrictors. These adverse reactions are, in general, dose-related. They may also result from hypersensitivity, idiosyncrasy, diminished tolerance by the patient or unintentional intravascular injection. Nervous system disorders, local injection site reaction, hypersensitivity, cardiac disorders and vascular disorders are the most frequently occurring adverse reactions.
DOSE: Refer to datasheet for dosing and administration details.
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
NP21459 - Aug 2024