DENTOMYCIN Periodontal gel (2018)

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Περιεχόμενα

1. Name of the medicinal product

DENTOMYCIN 2% w/w Periodontal Gel.

2. Qualitative and quantitative composition

Minocycline hydrochloride dihydrate equivalent to minocycline 2% w/w. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Periodontal Gel. A Light yellow-coloured gel.

4.1. Therapeutic indications

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.

4.2. Posology and method of administration

Route of administration DENTOMYCIN is intended to be applied directly into the periodontal pocket by means of the specially designed applicator. Adults DENTOMYCIN should be administered following scaling ...

4.3. Contraindications

Known hypersensitivity to tetracyclines; complete renal failure; children under the age of 12 years.

4.4. Special warnings and precautions for use

Because of the potential for the development of sensitisation following subgingival administration, the treatment area should be closely observed. If signs and/or symptoms of sensitisation (itching, swelling, ...

4.5. Interaction with other medicinal products and other forms of interaction

Tetracyclines depress plasma prothrombin activity. Reduced doses of concomitant anticoagulants may therefore be necessary. The relevance of this statement to DENTOMYCIN has not been established. Cross-resistance ...

4.6. Pregnancy and lactation

Use in pregnancy There are no specific data available on the use of DENTOMYCIN in pregnancy. Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can ...

4.7. Effects on ability to drive and use machines

Not Applicable.

4.8. Undesirable effects

The most commonly reported adverse event is local irritation, occurring in less than 2% of patients. Adverse reactions associated with the systemic administration of minocycline are thought to be much ...

4.9. Overdose

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 ...

5.1. Pharmacodynamic properties

Minocycline hydrochloride has in vitro antibacterial activity against a wide range of gram-negative and gram-positive organisms thought to be related to periodontal disease, including Porphyromonas ...

5.2. Pharmacokinetic properties

In a pharmacokinetic study, concentrations of minocycline in gingival crevicular fluid remained at clinically-effective levels for a minimum of three days following the administration of 0.05g gel (1mg ...

5.3. Preclinical safety data

Nothing of further relevance to the prescriber.

6.1. List of excipients

Hyetellose Magnesium chloride hexahydrate (E511) Ammonio methacrylate Copolymer (Type B) Ph. Eur. Triacetin (E1518) Glycerol (E422)

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

At 2-8°C: 3 years. Up to 30°C: 10 days. See section 6.4 For in-use information, see section 4.2.

6.4. Special precautions for storage

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 ...

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

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 ...

7. Marketing authorization holder

Henry Schein UK Holdings Limited, Medcare House, Centurion Close Gillingham Business Park, Gillingham Kent, ME8 0SB, United Kingdom

8. Marketing authorization number(s)

PA1321/001/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 10 December 1998 Date of last renewal: 10 December 2008

10. Date of revision of the text

November 2018

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