ATRIDOX 44 Milligram Powder and solvent for gingival gel
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
11-05-2024
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Tuma ombi.
Viambatanisho vya kazi:
DOXYCYCLINE
Inapatikana kutoka:
Tolmar GmbH
INN (Jina la Kimataifa):
DOXYCYCLINE
Kipimo:
44 Milligram
Dawa fomu:
Powder and solvent for gingival gel
Dawa ya aina:
Product subject to prescription which may not be renewed (A)
Idhini hali ya:
Withdrawn
Idhini ya tarehe:
0000-00-00
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atridox 44 mg powder and solvent for gingival gel, pre-filled syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe B contains doxycycline hyclate equivalent to 44 mg doxycycline.
After reconstitution: 502 mg of gel contains 44 mg doxycycline (8.8% w/w) as doxycycline hyclate.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for gingival gel.
Syringe A and Syringe B: Syringe A contains a colourless gel. Syringe B contains a yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in adults with chronic periodontitis at sites with probing depths of > 5 mm, as an adjunct to conventional non-
surgical management of periodontal disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gingival use.
Atridox is intended for adults and the elderly.
Atridox is not indicated for use in children and adolescents to 18 years of age.
Atridox should only be administered by dental care professionals.
The final blended product is 502 mg of formulation containing 44 mg of doxycycline (8.8% w/w doxycycline) and is
sufficient material to treat up to sixteen sites with pocket depths averaging 6 mm.
Atridox is a variable dose product dependent on size, shape and number of pockets being treated. Atridox is intended
for immediate use and for use in only one patient. Detailed instructions on administering the product are contained in
section 6.6. Instructions for use and handling.
Following placement via a syringe, if necessary Atridox is packed into the pocket with a dental instrument until the
pocket is completely filled with coagulated material.
Mechanical oral hygiene procedures other than brushing the occlusal surfaces of the dentition and the ton
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