- Approval Id
- 2fbe5bad8e916bdf
- Drug Name
- PerioChip
- Product Name
- PerioChip
- Approval Number
- SIN13278P
- Approval Date
- 2007-05-21
- Registrant
- APEX PHARMA MARKETING PTE. LTD.
- Licence Holder
- APEX PHARMA MARKETING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- LINER, DENTAL
- Dosage
- **DOSAGE AND ADMINISTRATION**
One PerioChip is inserted into a periodontal pocket with probing pocket depth (PD) ≥ 5 mm. Up to 8 PerioChips may be inserted in a single visit. Treatment is recommended to be administered once every three months in pockets with PD remaining ≥ 5 mm.
The periodontal pocket should be isolated and the surrounding area dried prior to chip insertion. The PerioChip should be grasped using forceps (such that the rounded end points away from the forceps) and inserted into the periodontal pocket to its maximum depth. If necessary, the PerioChip can be further maneuvered into position using the tips of the forceps or a flat instrument. The PerioChip does not need to be removed since it biodegrades completely.
In the unlikely event of PerioChip dislodgement (in the two pivotal clinical trials, only 8 chips were reported lost), several actions are recommended, depending on the day of PerioChip loss. If dislodgement occurs 7 days or more after placement, the dentist should consider the subject to have received a full course of treatment. If dislodgement occurs within 48 hours after placement, a new PerioChip should be inserted. If dislodgement occurs more than 48 hours after placement, the dentist should not replace the PerioChip, but reevaluate the patient at 3 months and insert a new PerioChip if the pocket depth has not been reduced to less than 5 mm.
- Route Of Administration
- PERIODONTAL
- Indication Info
- **INDICATIONS AND USAGE**
PerioChip is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. PerioChip may be used as a part of a periodontal maintenance program, which includes good oral hygiene and scaling and root planing.
- Contraindications
- **CONTRAINDICATIONS**
PerioChip should not be used in any patient who has a known sensitivity to chlorhexidine.
- Atc Code
- A01AB03
- Atc Item Name
- chlorhexidine
- Pharma Manufacturer Name
- APEX PHARMA MARKETING PTE. LTD.
- Company Detail Path
- /organization/apex-pharma-marketing-pte-ltd
