Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Henry Schein UK Holdings Limited, Medcare House, Centurion Close Gillingham Business Park, Gillingham Kent, ME8 0SB, United Kingdom
DENTOMYCIN is indicated for the treatment of moderate to severe chronic adult periodontitis. It should be used as an adjunct to conventional scaling and root planing, in pockets of 5mm or greater.
DENTOMYCIN is intended to be applied directly into the periodontal pocket by means of the specially designed applicator.
DENTOMYCIN should be administered following scaling and root planing, to peridontal pockets with a probing depth of at least 5 mm. The tip of the applicator should be inserted to the point of resistance in each pocket to be treated, before the medication is administered. The amount of gel administered should be sufficient to fill each pocket to the point of overflow.
The applicator should be wiped with 70% ethanol between applications to each individual tooth to avoid transfer of bacteria between periodontal pockets.
Each disposable applicator should be used for a single patient to treat a number of periodontal pockets. However a new applicator must be used at each visit. Treatment should be initiated with applications every 14 days for a total of three to four applications (e.g. 0, 2, 4 and 6 weeks). Treatment with the gel should not normally be repeated within 6 months of initial therapy.
Tooth brushing, flossing, mouth-washing, drinking or eating should be avoided for at least 2 hours immediately following administration of medication.
As adults, although caution should be exercised in patients with hepatic dysfunction or severe renal impairment.
The use of tetracyclines during tooth development in children under the age of 12 years may cause permanent discolouration. Enamel hypoplasia has also been reported. DENTOMYCIN is therefore contraindicated in children of this age group. There are no data to support the use of DENTOMYCIN in children over 12 years of age and therefore its use cannot be recommended.
Overdose with DENTOMYCIN is thought to be highly unlikely due to the small quantities per syringe. If however it were to occur, the treatment for minocycline overdose is gastric lavage plus appropriate supportive treatment. There is no specific antidote.
At 2-8°C: 3 years.
Up to 30°C: 10 days.
See section 6.4
For in-use information, see section 4.2.
Store in a refrigerator (2-8°C) in the original packaging. Do not freeze.
Product may be stored at temperatures up to 30°C for a maximum period of 10 days.
See Section 6.6.
Product should not be removed from the aluminium pouch until immediately before use.
0.5g of gel contained in an applicator consisting of a polypropylene syring barrel, polypropylene plunger rod and elastomer cap and gasket (plunger stopper) encased in a laminated aluminium pouch.
Each carton contains 5 applicators.
It is recommended that applicators are allowed to equilibrate to room temperature for approximately 15 minutes prior to use. See section 4.2 (Posology and method of administration).
Any unused product or waste material should be disposed of in accordance with local requirements.
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