CHLORHEXIDINE LACER MOUTHWASH

国家: 以色列

语言: 英文

来源: Ministry of Health

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资料单张 资料单张 (PIL)
30-05-2022
产品特点 产品特点 (SPC)
04-01-2022
公众评估报告 公众评估报告 (PAR)
04-01-2022

有效成分:

CHLORHEXIDINE DIGLUCONATE

可用日期:

TARO INTERNATIONAL LTD, ISRAEL

ATC代码:

A01AB03

药物剂型:

SOLUTION (ORAL)

组成:

CHLORHEXIDINE DIGLUCONATE 0.12 %W/V

给药途径:

LOCAL ORAL

处方类型:

Not required

厂商:

LACER S.A., SPAIN

治疗领域:

CHLORHEXIDINE

疗效迹象:

1. As an aid to maintaining oral hygiene. 2. As an aid in the treatment and prevention of gingivitis. 3. Inhibition of formation of dental plaque. 4. For use in aphtous ulceration and oral candidal infections (e.g. denture stomatitis and thrush). 5. For use in a post- periodontal surgery or treatment regimen to promote gingival healing.

授权日期:

2019-01-01

资料单张

                                Page 1 of 5
CHX Lacer MW – PIL Notif 12.2021 Clean
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed without a doctor's prescription
CHLORHEXIDINE LACER MOUTHWASH
NAME AND CONCENTRATION OF ACTIVE INGREDIENT: CHLORHEXIDINE DIGLUCONATE
0.12% W/V
Inactive ingredients and allergens: see section 2 ‘Important
information about some of this
medicine's ingredients’ and section 6 'Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your
doctor or pharmacist.
THIS MEDICINE IS INTENDED FOR USE IN PATIENTS OVER 12 YEARS OLD.
CONSULT YOUR DOCTOR BEFORE
USE IN YOUNGER PATIENTS.
Use this medicine according to the instructions in the section about
dose in this leaflet.
Consult your pharmacist if you need further information. Consult your
doctor if your
symptoms of illness get worse or do not improve.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
As an aid in the treatment and prevention of gum inflammation
(gingivitis).
•
For use following dental surgery or treatments, to promote healing of
the gums.
•
For use in mouth ulcers, inflammations due to dentures, and oral
thrush.
•
As an aid to maintaining oral hygiene.
•
Inhibition of formation of dental plaque.
THERAPEUTIC GROUP: antiseptic
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
YOU HAVE HAD AN ALLERGIC REACTION to chlorhexidine digluconate or to
any of this medicine’s
ingredients.
SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE
Page 2 of 5
CHX Lacer MW – PIL Notif 12.2021 Clean
•
DO NOT USE ANYWHERE OTHER THAN IN YOUR MOUTH. Do not swallow. In case
of contact with
the eyes or ears, rinse thoroughly with water.
•
IN CASE OF A SEVERE ALLERGIC REACTION, STOP USING THIS MEDICINE AND
GET HELP
IMMEDIATELY. See ‘Side effects’.
•
DO NOT USE IMMEDIATELY AFTER YOU BRUSH TEETH. See ‘How to use this
medicine’ for more
information.
•

                                
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产品特点

                                _This leaflet format has been determined by the Ministry of Health and
the content has been checked and _
_approved in January 2019_
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Lacer Mouthwash
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Digluconate 0.12% w/v
(equivalent to Chlorhexidine Digluconate Solution 0.636% w/w)
Also contains PEG-40 Hydrogenated Castor Oil. For a full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal solution
Colourless solution and with a characteristic odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antibacterial solution for the disinfection of the mouth.
1.
As an aid to maintaining oral hygiene.
2.
As an aid in the treatment and prevention of gingivitis.
3.
Inhibition of formation of dental plaque.
4.
For use in aphtous ulceration and oral candidal infections (e.g.
denture stomatitis and thrush).
5.
For use in a post- periodontal surgery or treatment regimen to promote
gingival healing.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
Thoroughly rinse the mouth for about one minute with 15 ml twice
daily. Spit out after use. In the
dental surgery, the patient should be instructed to rinse the mouth
for one minute prior to treatment.
For the treatment of gingivitis, a course of about one month is
advisable although some variation in
response is to be expected. In the case of aphthous ulceration and
oral candidal infections treatment
should be continued for 48 hours after clinical resolution. For the
treatment of dental stomatitis, the
dentures should be cleansed and soaked in Chlorhexidine Lacer
Mouthwash for fifteen minutes twice
daily.
Do not exceed the stated dose.
Children and the Elderly
Page
1
of
5
Cholrexidine Lacer Mouthwash – SmPC final
The normal adult dose is appropriate for elderly patients and children
of 12 years and over unless
otherwise recommended by the dentist or the physician.
Children under 12 years of age should not use the product unless
recommended by a healthcare
professional.

                                
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