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SEPTANEST is a brand name for Articaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Local and loco-regional anaesthesia in dental procedures. Septanest/Artikent/Bartinest/Isonest 1:200,000 is indicated in adults, adolescents and children above 4 years of age (or from 20 kg (44 lbs) of body weight).
Verbatim from this product's MHRA label. Tap a section to expand.
For professional use by physicians or dentists only. Posology For all populations, the lowest dose leading to effective anaesthesia should be used. The necessary dosage must be determined on an individual basis. For a routine procedure, the normal dose for adult patients is of 1 cartridge, but the contents of less of a cartridge may be sufficient for effective anaesthesia.
At the discretion of the dentist, more cartridges may be required for more extensive procedures without exceeding the maximum recommended dose. Septanest/Artikent/Bartinest/Isonest 1:200,000 is indicated for use in most routine dental procedures.
Septanest/Artikent/Bartinest/Isonest 1:100,000 is also available and is preferable for use in more complex procedures, such as requiring pronounced hemostasis. 5). ● Adults and adolescents (12 to 18 years of age) In adults and adolescents, the maximum articaine dose is 7 mg/kg with an absolute maximum articaine dose of 500 mg.
The maximum articaine dose of 500 mg corresponds to a healthy adult of more than 70 kg body weight. 5 cartridges) ● Children (4 to 11 years of age) The safety of Septanest/Artikent/Bartinest/Isonest 1:200,000 in children aged 4 years and below has not been established.
No data are available. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. The average effective dose of articaine is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively.
The lowest dose providing effective dental anaesthesia should be used. In children aged 4 years (or from 20 kg (44 lbs) of body weight) and above, the maximum dose of articaine is 7 mg/kg only with an absolute maximum dose of 385 mg articaine for a healthy child of 55 kg body weight.
2). Elevated product plasma levels may occur in these patients in particular after repeated use. 9). Patients with hepatic impairment Particular precaution should be used in order to administer the lowest dose leading to efficient anaesthesia in patients with hepatic impairment, in particular after repeated use, although 90% of articaine is first inactivated by unspecific plasma esterases in the tissue and blood.
2. Therefore, the lowest dose leading to effective anaesthesia should be used. Method of Administration Infiltration and perineural use in oral cavity. Local anaesthetics should be injected with caution when there is inflammation and/or infection at the site of the injection.
a) Summary of the safety profile Adverse reactions following administration of articaine / adrenaline 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, or diminished tolerance by patient. Nervous system disorders, local injection site reaction, hypersensitivity, cardiac disorders and vascular disorders are the most frequently occurring adverse reactions.
Serious adverse reactions are generally systemic. b) Tabulated list of adverse reactions The reported adverse reactions come from spontaneous reporting, clinical studies and literature.
The frequencies classification follows the convention:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000) Not known (cannot be estimated from the available data)”. , taste metallic, taste disturbance) Ageusia Allodynia Thermohyperesthesia Headache Uncommon Burning sensation Rare Facial nerve disorder2 (palsy, paralysis and paresis) Horner’s syndrome (eyelid ptosis, enophthalmos, miosis).
Somnolence (Drowsiness) Nystagmus Nervous system disorders Very rare Paresthesia3 (persistent hypoesthesia and gustatory loss) after mandibular or inferior alveolar nerve blocks Eye disorders Rare Diplopia (paralysis of oculomotor muscles)4 Visual impairment (temporary blindness)4 Ptosis Miosis Enophthalmos Ear and labyrinth disorders Rare Hyperacusis Tinnitus4 Cardiac disorders Common Bradycardia Tachycardia Rare Palpitations Not known Conduction disorders (atrioventricular block) Common Hypotension (with possible circulatory collapse) Uncommon Hypertension Rare Hot flush Vascular disorders Not known Local / Regional hyperaemia Vasodilatation Vasoconstriction Rare Bronchospasm / asthma Dyspnoea2 Respiratory, thoracic and mediastinal disorders Not known Dysphonia (Hoarseness)1 Common Swelling of tongue, lip, gums Uncommon Stomatitis, glossitis Nausea, vomiting, diarrhoea Rare Gingival / oral mucosal exfoliation (sloughing) / ulceration Gastrointestinal disorders Not known Dysphagia Swelling of cheeks Glossodynia Uncommon Rash (eruption) Pruritus Rare Angioedema (face / tongue / lip / throat / larynx / periorbital oedema) Urticaria Skin and subcutaneous tissue disorders Not known Erythema Hyperhidrosis Uncommon Neck pain Rare Muscle twitching4 Musculoskeletal and connective tissue disorders Not known Aggravation of the neuromuscular manifestations in Kearns-Sayre syndrome Trismus Uncommon Injection site pain Rare Injection site exfoliation / necrosis Fatigue, asthenia (weakness)/ Chills General disorders and administration site conditions Not known Local swelling Feeling hot, Feeling cold c) Description of selected adverse reactions 1 Allergic reactions should not be mistaken with syncopal episodes (cardiac palpitations due to adrenaline).
9) Special warnings This medicinal product must be used with special caution in patients with the following disorders and postponement of dental surgery should be considered if the condition is severe and/or unstable. g. g. 5) • Patients with uncontrolled hypertension • Concomitant treatment with tricyclic antidepressants, as these active substances can intensify the cardiovascular effects of adrenaline.
5) This medicinal product must be used with caution in patients with the following disorders: Patients with epileptic disease: Because of their convulsive actions, all local anaesthetics should be used very cautiously. Patients with plasma cholinesterase deficiency A plasma cholinesterase deficiency can be suspected when clinical signs of overdose occurs with usual dosage of anesthesia and when a vascular injection has been excluded.
In this case, caution shall be used for the next injection and reduced dose shall be applied.
Patients with renal disease:
The lowest dose leading to effective anaesthesia should be used.
Patients with severe hepatic disease:
This medicinal product should be used cautiously due to the presence of hepatic disease although 90% of articaine is first inactivated by unspecific plasma esterases in the tissue and blood.
Patients with myasthenia gravis treated by acetylcholinesterase inhibitors:
The lowest dose leading to effective anaesthesia should be used. Patients with porphyria Septanest/Artikent/Bartinest/Isonest 1:200,000 should only be used in patients with acute porphyria when no safer alternative is available. Appropriate precautions should be taken in all patients with porphyria, as this medicinal product can trigger porphyria.
1. - Patients with epilepsy not controlled by treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The rate of injection should be very slow (1 ml/min). Precautions to be taken before handling or administering the medicinal product This medicinal product should only be used by or under the supervision of physicians or dentists sufficiently trained and familiar with diagnosis and treatment of systemic toxicity.
The availability of appropriate resuscitation equipment and medication should be ensured before induction of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
The patient’s state of consciousness should be monitored after each local anaesthetic injection. When using Septanest/Artikent/Bartinest/Isonest 1:200,000 for infiltration or regional block anaesthesia, injection should always be made slowly and with prior aspiration.
6.
2 A 2 week delay in the onset of facial paralysis has been described following administration of articaine combined with adrenaline, and the condition was unchanged 6 months later. 3 These neural pathologies may occur with various symptoms of abnormal sensations.
, burning, pricking, tingling or itching) well beyond the expected duration of anesthesia. Most cases of paresthesia reported following dental treatment are transient and resolve within days, weeks or months. Persistent paresthesia, mostly following nerve blocks in the mandible, is characterized by slow, incomplete, or lack of recovery.
4 Several adverse events, like agitation, anxiety / nervousness, tremor, speech disorder may be warning signs before CNS depression. 9 of SmPC). d) Paediatric population The safety profile was similar in children and adolescents from 4 to 18 years old compared to adults.
However, accidental soft tissue injury was observed more frequently, especially in 3 to 7 year old children, due to the prolonged soft tissue anaesthesia. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5).
Patients receiving treatment with antiplatelets / anticoagulants:
Septanest/Artikent/Bartinest/Isonest 1:200,000 should be administered with caution in patients, who are using antiplatelet/anticoagulant medicines or are suffering from coagulation disorder, because of higher risk of bleeding. The higher risk of bleeding is more associated with the procedure, rather than with the medicine.
Elderly patients:
Elevated product plasma levels may occur in elderly patients in particular after repeated use. 9). Therefore, the lowest dose leading to effective anaesthesia should be used. g. heart failure, coronary heart disease, history of myocardial infarction, cardiac arrhythmia, hypertension) • Patients with cerebral circulation disturbances, history of strokes It is recommended that dental treatment with articaine/adrenaline be deferred for six months following a stroke due to the increased risk of recurrent strokes.
• Patients with uncontrolled diabetes: This medicinal product should be used cautiously due to hyperglycemic effect of adrenaline. • Patients with thyreotoxicosis: This medicinal product should be used cautiously due to the presence of adrenaline.
• Patients with pheochromocytoma: This medicinal product should be used cautiously due to the presence of adrenaline. • Patients with susceptibility of acute angle-closure glaucoma: This medicinal product should be used cautiously due to the presence of adrenaline.
The lowest dose leading to effective anaesthesia should be used. This medicinal product must be used safely and effectively under appropriate conditions: Adrenaline impairs the flow of blood in the gums, potentially causing local tissue necrosis.
Very rare cases of prolonged or irreversible nerve injury and gustatory loss have been reported after mandibular block analgesia. The local anaesthetic effects may be reduced when this medicinal product is injected into an inflamed or infected area.
The dose must also be reduced in case of hypoxia, hyperkalaemia and metabolic acidosis. Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until normal sensation is restored.
Excipients with known effect:
This medicinal product contains sodium metabisulfite, a sulfite that may rarely cause hypersensitivity reactions and bronchospasm. e. it is considered as essentially “sodium free”. 3).
Precautions for use Risk associated with accidental intravascular injection:
Accidental intravascular injection may cause sudden high levels of adrenaline and articaine in the systemic circulation. This […]