PERIO-CHIP

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CHLORHEXIDINE DIGLUCONATE

Available from:

DEXCEL PHARMA TECHNOLOGIES LTD

ATC code:

A01AB03

Pharmaceutical form:

CHIP

Composition:

CHLORHEXIDINE DIGLUCONATE 2.5 MG

Administration route:

INTRA-PERIODONTAL POCKET

Prescription type:

Required

Manufactured by:

DEXCEL PHARMA TECHNOLOGIES LTD

Therapeutic group:

CHLORHEXIDINE

Therapeutic area:

CHLORHEXIDINE

Therapeutic indications:

The Perio- chip is indicated for reduction and/or elimination of pathogenic periodontal pocket microbiota, delaying and/or arresting recolonization of the subgingival microflora, reduction and/or elimination of inflammatory lesions in the periodontal pockets, and as an adjunct to mechanical treatment in Periodontitis.

Authorization date:

2014-02-28

Patient Information leaflet

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05.2013
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24
םושירה רפסמו תילגנאב רישכת םש
PERIOCHIP
(062 94 27005 00)
םושירה לעב םש לסקד
תויגולונכט המראפ
עב
"
מ
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
טסקט
שדח
INDICATION
CONTRAINDICATIONS
Hypersensitivity to
chlorhexidine
digluconate or to any of
the excipients.
Known sensitivity to chlorhexidine or
hypersensitivity to chlorhexidine digluconate
or to any of the excipients listed in section 6.1-
`List of excipients`.
POSOLOGY, DOSAGE &
ADMINISTRATION
Dosage
_Adults including the _
_elderly:_ Following
mechanical debridement,
a PerioChip is placed in
each of the periodontal
pockets to be treated.
Retreatment with
PerioChip following
mechanical plaque
removal at 3 month
intervals may provide
additional benefit if
pocket depth remains
≥
5mm.
The PerioChip
biodegrades in the
periodontal pocket over
about a 7-day period and
Dosage
_Adults including the elderly:_ Following
mechanical debridement, a PerioChip is
placed in each of the periodontal pockets to
be treated. One PerioChip is inserted into a
periodontal pocket with probing pocket depth
(PD) 5 mm or greater . Up to 8 chips may be
inserted in a single visit. Retreatment with
PerioChip following mechanical plaque
removal at 3 month intervals may provide
additional benefit if pocket depth remains
≥
5mm.
The PerioChip biodegrades in the periodontal
pocket over about a 7-day period and no
return visit to the dental clinic to remove the
dental insert is necessary. The patient should
be instructed to continue normal oral hygiene
procedures. No restrictions on dietary habits
no return visit to the

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PerioChip
®
, 2.5 mg Periodontal Insert
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each periodontal insert_ _contains chlorhexidine digluconate 2.5 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Periodontal insert (chip).
Bullet shaped, orange brown periodontal insert.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The PerioChip is indicated for reduction and/or elimination of
pathogenic periodontal pocket microbiota,
delaying and/or arresting recolonization of the subgingival
microflora, reduction and/or elimination of
inflammatory lesions in the periodontal pockets, and as an adjunct to
mechanical treatment in periodontitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
_Adults including the elderly:_ Following mechanical debridement, a
PerioChip is placed in each of the periodontal
pockets to be treated. One PerioChip is inserted into a periodontal
pocket with probing pocket depth (PD)
5 mm or greater. Up to 8 chips may be inserted in a single visit.
Retreatment with PerioChip following
mechanical plaque removal at 3 month intervals may provide additional
benefit if pocket depth remains

5mm.
The PerioChip biodegrades in the periodontal pocket over about a 7-day
period and no return visit to the dental
clinic to remove the periodontal insert is necessary. The patient
should be instructed to continue normal oral
hygiene procedures. No restrictions on dietary habits are needed.
_ _
_Children and adolescents:_ PerioChip is not indicated in children and
adolescents, since data on safety and
efficacy in this age group have not been established.
Method of administration
Isolate the periodontal pocket and dry the periodontal pocket and the
surrounding area. Open a blister cavity
containing one PerioChip. Pick up the periodontal insert with a pair
of forceps so that the rounded end points
away from the forceps. Rapidly insert the periodontal insert, curved
end first, into the periodontal pocket to its
maximum d