Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Chlorhexidine gluconate
Dexcel Pharma GmbH
A01AB; A01AB03
Chlorhexidine gluconate
2.5 milligram(s)
Periodontal insert
Product subject to prescription which may not be renewed (A)
Antiinfectives and antiseptics for local oral treatment; chlorhexidine
Not marketed
1998-03-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERIOCHIP ® 2.5MG PERIODONTAL INSERT (Chlorhexidine digluconate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ‐ Keep this leaflet. You may need to read it again. ‐ If you have any further questions, ask your dentist. ‐ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ‐ If you get any side effects, talk to your dentist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What PerioChip is and what it is used for 2. What you need to know before you use PerioChip 3. How to use PerioChip 4. Possible side effects 5. How to store PerioChip 6. Contents of the pack and other information 1. WHAT PERIOCHIP IS AND WHAT IT IS USED FOR WHAT IS PERIOCHIP PerioChip is a small chip containing the antimicrobial agent chlorhexidine digluconate. WHAT IS PERIOCHIP FOR Most people will at some stage of their lives suffer from gingivitis, which is inflammation of the gums. If gingivitis is left untreated, it may lead to periodontitis which can result in tooth loss. Periodontitis is a disease in which the tissues that support the teeth become inflamed and degenerate. This disease can be prevented by treating gingivitis in the early stages. If, however, gingivitis is not treated, the gums will be attacked by bacterial build-up known as plaque, causing the gum to become separated from the tooth and resulting in the formation of a periodontal pocket. Once a pocket has formed, plaque can build up and the disease can become worse. PerioChip is inserted by a dentist into the periodontal pocket to eliminate most of the disease- causing bacteria, to reduce the pocket inflammation and to decrease the depth of the pocket. PERIOCHIP IS USED IN COMBINATION WITH THE MECHANICAL REMOVAL OF PLAQUE IN THE TREATMENT OF CHRONIC INFLAMMATORY PERIODONTAL DISEASE IN ADULTS Citiți documentul complet
Health Products Regulatory Authority 03 March 2023 CRN00DDCY Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Periochip 2.5 mg Dental Insert 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each periodontal insert contains chlorhexidine digluconate 2.5 mg. Excipient(s): with known effect: For the full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Periodontal insert. Bullet-shaped, orange brown periodontal insert. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PerioChip with scaling and root planing is indicated as an adjunctive antimicrobial treatment for moderate to severe chronic periodontal disease in adults with pocketing. PerioChip may be used as part of a periodontal treatment programme. PerioChip is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _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 no return visit to the dental clinic to remove the peridontal 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 and dry the periodontal pocket. Open an aluminium 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 into the pocket to its maximum depth and release. The periodontal insert can be further manoeuvred into position using the tips of the forceps or a flat plastic instrument. PerioChip insertion into periodont Citiți documentul complet