CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH ORIGINAL FLAVOUR

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

CHLORHEXIDINE GLUCONATE

Dostupno od:

Ecolab Limited

ATC koda:

A01AB03

INN (International ime):

CHLORHEXIDINE GLUCONATE

Doziranje:

0.2 %w/v

Farmaceutski oblik:

Oromucosal Solution

Tip recepta:

Product not subject to medical prescription

Područje terapije:

chlorhexidine

Status autorizacije:

Marketed

Datum autorizacije:

2000-02-18

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Gluconate Antiseptic Mouthwash Original Flavour 0.2% w/v
Oromucosal Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 0.2% w/v.
Excipients:
Ponceau 4R 0.001%w/w
Macrogol glycerol hydroxystearate 0.7% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal Solution.
A clear pink solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chlorhexidine Gluconate Antiseptic Mouthwash is an antimicrobial
solution which inhibits the formation of dental
plaque. It is indicated as an aid to the treatment and prevention of
gingivitis and in the maintenance of oral hygiene,
particularly in situations where toothbrushing cannot be adequately
employed (eg following oral surgery or in
physically handicapped patients).
It is used to promote gingival healing following periodontal surgery,
to manage
recurrent oral ulceration.
Additionally it is useful in the treatment of denture stomatitis and
thrush.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Children, adults and the elderly._
Chlorhexidine Gluconate Antiseptic Mouthwash should be used as
required up to twice daily.
Rinse the mouth thoroughly for about 1 minute with 10 ml.
Prior to dental surgery, the patient should be instructed to
rinse the mouth with 10 ml for 1 minute.
In the treatment of gingivitis a course of about one month is
recommended (ie
two bottles).
For denture stomatitis cleanse and soak the denture in solution for 15
minutes twice daily.
In the case of
aphthous ulceration and oral candidal infections, treatment should be
continued for 48 hours after clinical resolution.
4.3 CONTRAINDICATIONS
Known hypersensitivity to the product or any of its components,
especially in those with a history of possible
chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Chlorhexidine Gluconate Antiseptic Mouthwash contains chlorhexidine.
Chlorhexidine is known to induce
hypersensitivi