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 s...
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...
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.
Cr...
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 an...
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 m...
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 appropr...
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
Porphyromo...
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 ...
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 re...
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.
...
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 prod...
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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