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Abridged Prescribing Data

XYLONOR SPRAY (SmPC 2018-11: revision 2018-10)

COMPOSITION: per metered dose: lidocaine 10 mg, cetrimide 0.1 mg. THERAPEUTIC INDICATIONS: topical anaesthesia and disinfection of the mucous membrane in the buccal cavity. DOSAGE AND ADMINISTRATION: one metered dose is usually sufficient. Two may be used. Up to 5 different areas may be treated simultaneously, no more than 3 doses in each quadrant, only one quadrant should be anaesthetized during one sitting. Not to be used in children under 4 years of age. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: XYLONOR SPRAY is contraindicated in patients with history of hypersensitivity to lidocaine, to cetrimide or to other components of the solution. SPECIAL WARNINGS: XYLONOR SPRAY should be used with caution if there is sepsis or extremely traumatised mucosa in the area of application and in persons with known drug sensitivities. The lowest dose resulting in effective anaesthesia should be used. Dosage should always be adapted to the age and the physical state of the patient. Avoid spraying back of throat or mouth. Caution should be exercised when the product is administered during early pregnancy or to nursing women. INTERACTIONS: Avoid concurrent use with beta-adrenergic blocking agents and cimetidine. UNDESIRABLE EFFECTS: Hypersensitivity, overdosage or diminished tolerance may result in excitatory and/or depressant CNS manifestations, depressant cardiovascular and respiratory system manifestations and allergic reactions. PHARMACEUTICAL PRECAUTIONS: store below 25°C. PHARMACEUTICAL FORM: metered dose aerosol (flask: 36 g). LEGAL CATEGORY: POM. FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LIMITED, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME160JZ, UK. PL 08313/0032 Available from your licensed dental wholesaler. Further information and SPC available on request.

LIGNOSPAN SPECIAL (SmPC 2018-07-26: revision 2017-12)

LIGNOSPAN SPECIAL (also branded as EUROCAINE, LIGNOKENT, REXOCAINE, UTILYCAINE) COMPOSITION: Lidocaine Hydrochloride 20 mg, Adrenaline 12.5 µg (as tartrate) (1:80,000). THERAPEUTIC INDICATIONS: local anaesthesia for dental procedures by infiltration or nerve block injection. DOSAGE AND ADMINISTRATION: The lowest dose leading to efficient anaesthesia should be used. Adults: the maximum recommended dose is 7 mg/kg of body weight for a healthy adult above 50 kg of body weight with an absolute maximum dose of 500 mg of lidocaine or 200 µg of adrenaline. Children and adolescents: Special care has to be exercised in children below 4 years. Dosage should be determined by their age and weight. The average dose is 20-30 mg lidocaine hydrochloride per session. Do not exceed 5 mg of lidocaine hydrochloride per kilogram of body weight. The solution is for a single use. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: Hypersensitivity to lidocaine (or to any local anaesthetic agent of the amide type) or to adrenaline or to any of the excipients (sodium chloride, potassium metabisulfite (E224), disodium edetate, sodium hydroxide and water for injections). LIGNOSPAN SPECIAL due to the presence of lidocaine is contra-indicated in patients suffering from: severe conduction disturbances (e.g., severe bradycardia, 2nd / 3rd degree AV blocks), acute intermittent porphyria. LIGNOSPAN SPECIAL due to the presence of adrenaline is contra-indicated in patients suffering from: uncontrolled /severe hypertension, persistent / refractory tachyarrhythmia, pheochromocytoma. SPECIAL WARNINGS: This product must be used with caution in: patients with cardiovascular disorders (peripheral vascular disease, arrhythmias particularly of ventricular origin, heart failure, hypotension), patients with myasthenia gravis, patients with epileptic disease, patients with hepatic disease, patients with renal disease, patients with thyrotoxicosis, patients with coronary artery disease and valvular cardiac disease, patients receiving treatment with antiplatelets / anticoagulants, patients with uncontrolled diabetes, patients with susceptibility of acute angle-closure glaucoma, patients under the influence of illicit drug, elderly patients. Adrenaline may cause local tissue necrosis. The local anaesthetic effects may be reduced if the product is injected into an inflamed or infected area. Risk of biting exists, avoid chewing gum or eating until sensation is restored. Accidental intravascular injection may be associated with severe adverse reactions (convulsions, central nervous system or cardiorespiratory depression, coma, respiratory arrest). Accidental intraneural injection may lead the drug to move in retrograde manner along the nerve. Because of the presence of adrenaline, precautions and monitoring should be enhanced in the following situations: patients stressed prior to dental procedure or conditions of use. The medicinal product contains potassium metabisulfite, a sulfite that may rarely cause hypersensitivity reactions and bronchospasm. INTERACTIONS: Concurrent use of postganglionic adrenergic blocking agents may result in risk of hypertension and other cardiovascular effects. Avoid concurrent use with other local anaesthetics, opioid sedatives, inhibitors of metabolism, halogenated volatile anaesthetics, non-selective beta-adrenergic blockers, trycyclic antidepressants, MAO inhibitors, Catechol-O-methyl transferase inhibitors, drugs with combination of adrenergic-serotoninergic effect, drugs causing arrhythmias in combination with adrenaline, ergot-type oxytocic drugs, sympathomimetic vasopressors and other sympathomimetics and phenothiazines. UNDESIRABLE EFFECTS: Hypersensitivity, overdosage or diminished tolerance may result in: nervous system disorders, cardiac disorders, respiratory disorders and vascular disorders. PHARMACEUTICAL PRECAUTIONS: Store below 25ºC. Keep the cartridges in the outer carton tightly closed, in order to protect from light. Do not freeze. PHARMACEUTICAL FORM: Solution for injection contained in 1.8 and 2.2 ml dental cartridges. LEGAL CATEGORY: POM. FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LIMITED, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME16 0JZ, UK. PL 08313/0019. Available from your licensed dental wholesaler. Further information and SPCs available on request.

SCANDONEST 2% SPECIAL (SmPC 2019-11: revision 2018-12)

COMPOSITION: Mepivacaine hydrochloride 20 mg, Adrenaline base 0.1 mg. THERAPEUTIC INDICATIONS: Local anaesthesia in the dental practice. DOSAGE AND ADMINISTRATION: Adults: 1 cartridge for routine work. Do not exceed 3 cartridges. Children from 4 years of age and older: the average dose is 0.0375 ml of mepivacaine solution per kg body weight. Do not exceed 0.15 ml per kg body weight. SCANDONEST 2% SPECIAL is administered by infiltration or nerve block injection. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: SCANDONEST 2% SPECIAL is contra-indicated in children below 4 years of age and in patients presenting allergy to amide type anaesthetics or to any component of the formulation. SCANDONEST 2% SPECIAL due to the presence of a vasoconstrictor (adrenaline), is contra-indicated in patients suffering from: arterial hypertension, cardiovascular disease, coronary disease, valvular affection or under MAOI or tricyclic anti-depressant treatment. SPECIAL WARNINGS: For professional dental use only. Should be used with caution in patients with peripheral vascular disease, hepatic disease, renal disease, a history of disturbances of cardiac rhythm or heart block, epilepsy or impaired respiratory function. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. Caution should be exercised when the product is administered during early pregnancy or to nursing women. Do not inject into a blood vessel. Aspiration should be performed before injection. Inject slowly. Local anaesthetic procedures should be used with caution where there is sepsis and/or inflammation in the region of infection. The lowest dosage that results in effective anaesthesia should be used. The product should not be injected repeatedly at the same site. The cartridge should be used on one patient during one session of treatment only. INTERACTIONS: Avoid concurrent use with phenothiazines, vasopressor drugs and ergot-type oxytocic drugs, beta- adrenergic drugs and chloroform, halothane, cyclopropane, trichloroethylene, or other related agents. Reduce doses of anaesthetic solution if sedatives are employed. Monoamine oxydase inhibitors and tricyclic antidepressants may increase the cardiovascular effects of adrenaline. UNDESIRABLE EFFECTS: Hypersensitivity, overdosage or diminished tolerance may result in: excitatory or depressant manifestations of the central nervous system, depressant cardiovascular manifestations and allergic reactions. PHARMACEUTICAL PRECAUTIONS: Store in the original package, in a dry place below 25°C and protect from light. PHARMACEUTICAL FORM: Solution for injection contained in 1.8 and 2.2 ml dental cartridges. LEGAL CATEGORY: POM. FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LIMITED, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME16 0JZ, UK. PL 08313/0026 Available from your licensed dental wholesaler. Further information and SPCs available on request.

SCANDONEST 3% PLAIN (SmPC 2018-11: revision 2018-07)

COMPOSITION: Mepivacaine hydrochloride 30 mg. THERAPEUTIC INDICATIONS: local and loco-regional anaesthesia in dental surgery. DOSAGE AND ADMINISTRATION: the lowest dose of anaesthetic leading to effective anaesthesia should be used. Adults: the maximum recommended dose is of 4.4 mg/kg of body weight with an absolute maximum recommended dose of 300 mg (10ml of solution) for the individuals above 70 kg of body weight. Children from 4 years of age and older: Dosage should be determined by their age and weight. The average dosage is 0.75 mg of mepivacaine per kg of body weight. Do not exceed 0.1ml of mepivacaine per kg of body weight. SCANDONEST 3% PLAIN is administered by infiltration and perineural injection. The solution is for a single use. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: SCANDONEST 3% PLAIN is contra-indicated in: children below 4 years of age, patients presenting allergy to amide type anaesthetics or to any component of the formulation, patients suffering from severe disorders of atrioventicular conduction not compensated by pacemaker, epileptic patients poorly controlled. SPECIAL WARNINGS: This product must be used with caution in: patients with cardiovascular disorders, epileptic patients, patients with a hepatic disease, patients with a kidey disease, patients with porphyria, patients with acidosis, elderly patients. For professional dental use only. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. Caution should be exercised when the product is administered during pregnancy or to nursing women. Inject very slowly. Local anaesthetic should be injected with caution where there is inflammation and/or infection at the site of the infection. Accidental intravascular injection may be associated with severe adverse reactions (convulsions, central nervous system or cardiorespiratory depression, coma, respiratory arrest). Accidental intraneural injection may lead the drug to move in retrograde manner along the nerve. INTERACTIONS: Avoid concurrent use with H2 antihistaminics, antiarrhythmic drugs, CYP1A inhibitors, propranolol. Reduce doses of anaesthetic solution if sedatives are employed. UNDESIRABLE EFFECTS: Hypersensitivity, overdosage or diminished tolerance may result in serious systemic adverse experiences (nervous system disorders, cardiac disorders). PHARMACEUTICAL PRECAUTIONS: Do not freeze. PHARMACEUTICAL FORM: Solution for injection contained in 1.7 and 2.2 ml dental cartridges. . LEGAL CATEGORY: POM. FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LIMITED, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME160JZ, UK. PL 08313/0023 Available from your licensed dental wholesaler. Further information and SPCs available on request.

SEPTANEST 1:100,000 (SmPC 2012-06: revision 2012-06)

SEPTANEST 1:100,000 (also branded as ARTIKENT 1:100,000, BARTINEST 1:100,000, ISONEST 1:100,000). COMPOSITION: cartridge of 1.7 ml (2.2ml): articaine hydrochloride 68 mg (88 mg), epinephrine bitartrate 30.94 µg (40.04 µg), adrenaline tartrate 17 µg (22 µg) expressed in base 1:100,000. THERAPEUTIC INDICATIONS: loco-regional dental anaesthesia in patients of at least 4 years in case of classic or muco-gingival operations or dental surgical procedures where bone removal is necessary. DOSAGE AND ADMINISTRATION: For most common operations, one infiltration with 1.7 ml is sufficient. Do not exceed the equivalent of 7 mg articaine hydrochloride per kilo of weight. Dosage in children should be commensurate with their weight. The recommended dose in 20 kg child is about ¾ cartridge of 1.7 ml or ½ cartridge of 2.2 ml. The maximum dose is about 2 cartridges of 1.7 ml or 1.5 cartridge of 2.2 ml. The recommended dose in 40 kg child is about 1.5 cartridge of 1.7 ml or 1 cartridge of 2.2 ml. The maximum dose is about 4 cartridges of 1.7 ml or 3 cartridges of 2.2 ml. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: Hypersensitivity to any local anaesthetic agent or any component of SEPTANEST. Do not use SEPTANEST in patients who have experienced bronchospasms after administration of products containing sulphites, patients with deficiency in plasma cholinesterase activity, patients receiving monoamine oxidase inhibitors or tricyclic anti-depressants, patients in whom general anaesthesia might be required to complete the procedure and in children under 4 years of age. Resuscitative equipment should be available for immediate use. SPECIAL WARNINGS: SEPTANEST should be used with caution in patients with hepatic disease, thyrotoxicosis, cardiovascular disease, abnormalities of cardiac conduction, epilepsy, and in diabetic patients. Intra-vascular injection is strictly contra- indicated. The local anaesthetic effects may be reduced if the product is injected into an inflamed or infected area. Inject slowly. The product should only be used in pregnancy when the benefits are considered to outweigh the risks. Breast feeding should be avoided for 48 hours after use of SEPTANEST. ABILITY TO DRIVE AND USE MACHINES: No demonstrated effects upon motor coordination, however subjects who suffer adverse effects should not drive or use machines until symptoms have resolved. INTERACTIONS: SEPTANEST should be administered with caution to any patient receiving drugs with sympathomimetic properties or with agents whose therapeutic actions may be antagonised by adrenaline. Articaine should be given with caution in patients receiving an antiarrhythmic agent. UNDESIRABLE EFFECTS: Hypersensitivity, overdosage or intra-vascular injection may result in CNS, respiratory, cardiovascular and allergic reactions. Patients with peripheral or hypertensive vascular disease may develop ischemic injury or necrosis. PHARMACEUTICAL PRECAUTIONS: Store in the original container, below 25°C. Protect from light. Do not freeze. PHARMACEUTICAL FORM: Solution for injection contained in 1.7 and 2.2 ml dental cartridges. LEGAL CATEGORY: POM. FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LTD, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME16 0JZ, UK. PL 08313/0039 Available from your licensed dental wholesaler. Further information and SPCs available on request.

SEPTANEST 1:200,000 (SmPC 2012-06: revision 2012-06)

SEPTANEST 1:200,000 (also branded as ARTIKENT 1:200,000, BARTINEST 1:200,000, ISONEST 1:200,000). COMPOSITION: cartridge of 1.7 ml (2.2ml): articaine hydrochloride 68 mg (88 mg), epinephrine bitartrate 15.47 µg (20.02 µg), adrenaline tartrate 8.50 µg (11 µg) expressed in base 1:200,000. THERAPEUTIC INDICATIONS: loco-regional dental anaesthesia in patients of at least 4 years in case of classic or muco-gingival operations. DOSAGE AND ADMINISTRATION: For most common operations, one infiltration with 1.7 ml is sufficient. Do not exceed the equivalent of 7 mg articaine hydrochloride per kilo of weight. Dosage in children should be commensurate with their weight. The recommended dose in 20 kg child is about ¾ cartridge of 1.7 ml or ½ cartridge of 2.2 ml. The maximum dose is about 2 cartridges of 1.7 ml or 1.5 cartridge of 2.2 ml. The recommended dose in 40 kg child is about 1.5 cartridge of 1.7 ml or 1 cartridge of 2.2 ml. The maximum dose is about 4 cartridges of 1.7 ml or 3 cartridges of 2.2 ml. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: Hypersensitivity to any local anaesthetic agent or any component of SEPTANEST. Do not use SEPTANEST in patients who have experienced bronchospasms after administration of products containing sulphites, patients with deficiency in plasma cholinesterase activity, patients receiving monoamine oxidase inhibitors or tricyclic anti- depressants, patients in whom general anaesthesia might be required to complete the procedure and in children under 4 years of age. Resuscitative equipment should be available for immediate use. SPECIAL WARNINGS: SEPTANEST should be used with caution in patients with hepatic disease, thyrotoxicosis, cardiovascular disease, abnormalities of cardiac conduction, epilepsy, and in diabetic patients. Intra-vascular injection is strictly contra-indicated. The local anaesthetic effects may be reduced if the product is injected into an inflamed or infected area. Inject slowly. The product should only be used in pregnancy when the benefits are considered to outweigh the risks. Breast feeding should be avoided for 48 hours after use of SEPTANEST. ABILITY TO DRIVE AND USE MACHINES: No demonstrated effects upon motor coordination, however subjects who suffer adverse effects should not drive or use machines until symptoms have resolved. INTERACTIONS: SEPTANEST should be administered with caution to any patient receiving drugs with sympathomimetic properties or with agents whose therapeutic actions may be antagonised by adrenaline. Articaine should be given with caution in patients receiving an antiarrhythmic agent. UNDESIRABLE EFFECTS: Hypersensitivity, overdosage or intra- vascular injection may result in CNS, respiratory, cardiovascular and allergic reactions. Patients with peripheral or hypertensive vascular disease may develop ischemic injury or necrosis. PHARMACEUTICAL PRECAUTIONS: Store in the original container, below 25°C. Protect from light. Do not freeze. PHARMACEUTICAL FORM: Solution for injection contained in 1.7 and 2.2 ml dental cartridges. LEGAL CATEGORY: POM. FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LTD, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME16 0JZ, UK. PL 08313/0038 Available from your licensed dental wholesaler. Further information and SPCs available on request.

XYLONOR GEL (SmPC 2019-11 : révision 2018-12)

COMPOSITION: 1g of gel contains 50 mg of lidocaine and 1.5 mg of cetrimide. THERAPEUTIC INDICATIONS: topical anaesthesia in the buccal cavity. DOSAGE AND ADMINISTRATION: Apply 0.1-0.5 g locally using cotton pellet. Gingival use. Not to be used in children under 4 years of age. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: XYLONOR GEL is contraindicated in patients with history of hypersensitivity to local anaesthetics of the amide type, to cetrimide or to other components of the gel. SPECIAL WARNINGS: XYLONOR GEL should be used with caution if there is sepsis or extremely traumatised mucosa in the area of application and in persons with known drug sensitivities. The lowest dose resulting in effective anaesthesia should be used. Dosage should always be adapted to the age and the physical state of the patient. Patients should not take any food before they have recovered sensitivity. There is a possibility of positive results on doping tests performed on sportsmen. Caution should be exercised when the product is administered during early pregnancy or to nursing women. INTERACTIONS: Soaps and anionic surfactants are known to decrease the bactericidal activity of cetrimide. UNDESIRABLE EFFECTS: systemic adverse reactions are extremely rare with lidocaine ointments. However, hypersensitivity, overdosage or diminished tolerance may result in excitatory and/or depressant CNS manifestations, depressant cardiovascular and respiratory system manifestations and allergic reactions. PHARMACEUTICAL PRECAUTIONS: The tube should be kept well-closed below 25°C in a dry place. PHARMACEUTICAL FORM: 15g tube of gel. LEGAL CATEGORY: P. FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LIMITED, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME16 0JZ, UK. PL 08313/0027 Available from your licensed dental wholesaler. Further information and SPCs available on request.