Страна: Израел
Език: английски
Източник: Ministry of Health
CHLORHEXIDINE DIGLUCONATE
DEXCEL PHARMA TECHNOLOGIES LTD
A01AB03
CHIP
CHLORHEXIDINE DIGLUCONATE 2.5 MG
INTRA-PERIODONTAL POCKET
Required
DEXCEL PHARMA TECHNOLOGIES LTD
CHLORHEXIDINE
CHLORHEXIDINE
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.
2014-02-28
לע העדוה לע העדוה לע העדוה הרמחה הרמחה הרמחה ) ) ) עדימ עדימ עדימ תוחיטב תוחיטב תוחיטב ( ( ( ל ןולעב ל ןולעב ל ןולעב אפור אפור אפור ) ) ) ןכדועמ ןכדועמ ןכדועמ 05.2013 05.2013 05.2013 ( ( ( ךיראת 4 2.201 1 . 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 Прочетете целия документ
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 Прочетете целия документ