ORAQIX

7 g) or less of Oraqix will be sufficient for one quadrant of the dentition. e. 5 mg prilocaine base. Fill the periodontal pockets with Oraqix, by means of a dental syringe or the Oraqix Dispenser and the blunt-tipped applicator included with the pack, until the gel becomes visible at the gingival margin.

Wait half a minute before starting treatment (a longer waiting time does not enhance the anaesthesia). The duration of anaesthesia, as assessed by probing of pocket depths, is about 20 minutes. If the anaesthesia starts to wear off, reapply Oraqix as needed.

If additional local anaesthesia is needed in combination with Oraqix, please refer to the specific Summary of Product Characteristics of each adjunctive anaesthetic. 9) it is not recommended to give any further local anaesthetics at the same treatment session, if the amount of Oraqix administered corresponds to the maximum recommended dose of five cartridges.

When administered, Oraqix should be a liquid. If it has formed a gel, it should be placed in a refrigerator until it becomes a liquid again. The air bubble visible in the cartridge will then move if the cartridge is tilted. The use of Oraqix in children and adolescents has not been assessed and therefore its use is not recommended in patients less than 18 years old.

Method of administration Periodontal use. Oraqix must not be injected.

The most frequent adverse events in all clinical trials were local reactions in the oral cavity. The frequency and type of reactions were very similar for Oraqix and placebo. For patients exposed to Oraqix and the placebo, 15% reported adverse events of mild intensity.

For both groups, 4% reported adverse events of moderate intensity. The local reactions reported, such as soreness, ulceration, irritation and redness, represent a pattern of symptoms normally found after scaling and root planing therapy.

Similar symptoms may also be associated with periodontal disease. Table 1. e. symptoms in the oral cavity 2 includes complaints of bad or bitter taste lasting for up to 4 hours after Oraqix administration 3 Allergic reactions have been reported in the postmarketing period.

Most often the reactions manifest as skin rashes, gingival redness and swelling. Occasionally, severe reactions including laryngeal edema and anaphylactoid reactions have occurred. 2 for additional information) causing cyanosis. Methaemoglobinaemia was not reported during clinical studies with Oraqix.

Oraqix must not be injected. Oraqix should be used with caution in patients with severe impairment of renal or hepatic function. With short-term treatment it is unlikely that either lidocaine, prilocaine or their respective metabolites will accumulate significantly.

g. grade II and III AV block, pronounced bradycardia). Similarly, it should be used with caution in patients who are in remission from porphyria or who are asymptomatic carriers of the mutated genes that are responsible for the development of porphyria.

2 Pharmacokinetics). The use of Oraqix in children and adolescents has not been assessed. Isolated cases of methaemoglobinaemia in children using the combination of lidocaine and prilocaine in other medicinal products have been reported.

Care should be taken not to allow Oraqix to come in contact with the eyes as it may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, immediately rinse the eye in water or sodium chloride solution and protect it until sensation returns.

When Oraqix is used, the patient should be aware that its use may be accompanied by a block of all sensations in the treated area and, if inadvertently spread may induce numbness of the oral mucosa. Care should be taken to avoid excess Oraqix gel from spreading to the oro-pharyngeal mucosa.

The patient should avoid inadvertent trauma to the treated area, exposure to extreme hot or cold temperatures and refrain from eating and drinking until complete sensation has returned. Oraqix should not be applied to ulcerative lesions or during acute infections of the oral cavity.

Persons applying or removing the gel should ensure that contact is avoided in order to prevent the development of hypersensitivity. This product contains an active ingredient that may interfere with tests for substances prohibited in sportswomen and sportsmen.

Oraqix is contraindicated in patients with a history of hypersensitivity to lidocaine, to prilocaine, to local anaesthetics of the amide type or to any excipients. Oraqix is contraindicated in patients with congenital or idiopathic methaemoglobinaemia.

Oraqix is contraindicated in patients with recurrent porphyria.