ORABLOC

8 ml per tooth is usually sufficient. 8 ml may be necessary to achieve complete anaesthesia. Injection via the painful palatine route is normally not necessary. 1 ml per puncture is sufficient. Where multiple extractions of adjacent teeth are necessary, it is possible in most cases to reduce the number of vestibular injections required.

8 ml per tooth is usually sufficient. 8 ml is recommended. Conventional mandibular anaesthesia is indicated only where the above-mentioned procedure does not result in a complete anaesthesia. For surgical operations, it is recommended that the dose of Orabloc be adjusted individually based on the operation’s severity and duration.

Over the course of treatment, adults may be given up to 7 mg articaine per kg body weight. 5 ml of solution for injection) were well tolerated. Elderly patients and patients with severe hepatic and renal dysfunction Increased plasma articaine levels may occur in elderly patients and in patients with severe hepatic and renal dysfunction.

In such patients, particular care should be taken to use the minimum dose needed to achieve required anaesthesia. Paediatric population When using Orabloc in children and adolescents, the minimum volume necessary to achieve adequate anaesthesia should be used; the injection amount should be individually tailored to the age and weight of the child and adolescent.

A maximum dose of 5 mg articaine per kg of body weight should not be exceeded. This product has not been studied in children less than 1 year old. Method of administration For use in dental anaesthesia only. Before injection, aspiration is always recommended to avoid intravascular injection.

e. needle rotation by 90° or even better by 180°. 2 ml and slow application of the rest – not earlier than 20–30 seconds later. g. hepatitis transmission), syringe and needles used to draw up the solution must always be fresh and sterile.

For single use. Any unused solution should be discarded. This medicinal product should not be used if cloudy or discoloured.

000) Not known (cannot be estimated from the available data) Immune system disorders Not known: Allergic or allergy-like hypersensitivity type reactions. These may manifest themselves as oedematous swelling and/or inflammation at the injection site or manifestations appearing independently of the site may include skin reddening, itching, conjunctivitis, rhinitis, facial swelling (angioedema) with swelling of the upper and/or lower lip and/or cheeks, glottal oedema with globus pharyngis and difficulty in swallowing, urticaria and difficulty in breathing which may progress to anaphylactic shock.

Nervous system disorders Common: paresthesia, hypoesthesia; headaches, due presumably to the adrenaline component. Uncommon: dizziness Not known: - Dose-related (particularly at excessively high dosages or after inadvertent intravascular injection), central nervous system reactions may occur: agitation, nervousness, stupor sometimes progressing to loss of consciousness, coma, respiratory disorders sometimes progressing to respiratory arrest, muscular tremor and muscular twitching sometimes progressing to generalised convulsions.

g. facial nerve paresis) and reduced gustatory sensitivity in the orofacial regionare not side effects specific to articaine. However, such reactions are theoretically possible with any dental intervention, due to anatomical conditions in the injection area or incorrect injection techniques.

Eye disorders Not known:

Temporary visual disturbances (blurred vision, blindness, double vision) occurring during or shortly after injection of local anaesthetics in the area of the head. Cardiac disorders Uncommon: tachycardia Not known: cardiac arrhythmias, rise in blood pressure, hypotension, bradycardia, cardiac failure and shock (possibly life-threatening).

Respiratory, thoracic and mediastinal disorders Not know: respiratory dysfunction (tachypnea, bradypnea) that may lead to apnea Gastrointestinal disorders Common: Nausea, vomiting. 2). On account of its sodium metabisulphite content, the product can precipitate hypersensitivity reactions, particularly in patients with bronchial asthma.

In patients with cholinesterase deficiency, Orabloc must only be given in the presence of compelling indications, since its action is likely to be prolonged and may sometimes be too strong. g. heart failure, coronary heart disease, angina pectoris, history of myocardial infarction, cardiac arrhythmia, hypertension), - arteriosclerosis, - cerebral circulation disturbances, history of strokes, - chronic bronchitis, pulmonary emphysema, - diabetes mellitus, - severe anxiety.

Injection into an inflamed (infected) area is discouraged (increased uptake of Orabloc with reduced efficacy). Before using this product it is necessary to ask the patient questions on medical history, concomitant treatment and to keep verbal contact with patient, and to practice an injection test with 5 or 10% of the dose in case of risk of allergy.

To avoid occurrence of adverse effects the following must be taken into account: - choose the lowest possible dose, - before injection, aspiration in two stages (to avoid inadvertent intravascular injection). Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available (Oxygen, anticonvulsive drugs as benzodiazepines or barbiturates, muscle relaxants, atropin and vasopressin or epinephrine (adrenalin) in case of severe allergic or anaphylactic reactions).

It is recommended that the patient refrain from eating until the anaesthesia has worn off. Paediatric population Carers of young children should be warned of the risk of accidental soft tissue injury due to self-biting, due to prolonged soft tissue numbness.

This medicinal product contains metabisulphite (E223) which may rarely cause severe hypersensitivity reactions and bronchospasm. e. essentially ‘sodium-free’.

1. g. 2nd or 3rd degree AV block, marked bradycardia), - acute decompensated heart failure (acute congestive heart failure), - severe hypotension, - children under 4 years of age. g. propranolol), (risk of hypertensive crisis or severe bradycardia), - patients with phaeochromocytoma, - patients with severe hypertension, - concomitant treatment with tricyclic antidepressants or MAO inhibitors, as these active substances can intensify the cardiovascular effects of adrenaline (epinephrine).

This can occur up to 14 days after MAO inhibitor treatment has ended. Intravenous use is contraindicated. Orabloc must not be used in persons with bronchial asthma with hypersensitivity to sulphites. In such individuals, Orabloc may precipitate acute allergic reactions with anaphylactic symptoms, such as bronchospasm.