Aquasept Skin Cleanser 20mg/ml Cutaneous Solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Triclosan

Boleh didapati daripada:

Ayrton Saunders (Ireland) Limited

Kod ATC:

D08AE; D08AE04

INN (Nama Antarabangsa):

Triclosan

Dos:

20 milligram(s)/millilitre

Borang farmaseutikal:

Cutaneous solution

Kawasan terapeutik:

Phenol and derivatives; triclosan

Status kebenaran:

Not marketed

Tarikh kebenaran:

1992-04-22

Ciri produk

Health Products Regulatory Authority
02 December 2019
CRN009DYJ
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aquasept Skin Cleanser 20mg/ml Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20mg Triclosan
Excipients: also contains chlorocresol 0.25% w/v, and Propylene glycol
5% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A clear blue aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This product has an antibacterial effect and is intended for the
following uses:
For skin disinfection prior to surgery and for routine skin cleansing
to reduce the risk of cross-infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For pre-operative hand disinfection (100ml, 250ml, 500ml, 5l):
Wet area to be cleansed. Apply about 5ml of Aquasept and wash for one
minute, paying particular attention to the area around
the fingernails and cuticles and between the fingers. Rinse and repeat
for two minutes. Rinse thoroughly and dry hands with a
sterile towel.
Antiseptic skin cleanser (100ml, 250ml, 500ml, 5l):
Wet area to be cleansed and use Aquasept as a liquid soap, washing
thoroughly for one minute. Rinse and dry thoroughly.
4.3 CONTRAINDICATIONS
Hypersensitivity to triclosan or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Avoid contact with eyes or mucous membranes.
Keep out of reach of children.
Do not apply to broken skin.
Some product excipients may give rise to allergic reactions in some
people. In this instance, discontinue use and seek medical
advice.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None stated.
4.6 FERTILITY, PREGNANCY AND LACTATION
None stated.
Health Products Regulatory Authority
02 December 2019
CRN009DYJ
Page 2 of 3
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8 UNDESIRABLE EFFECTS
There have been isolated reports of contact dermatitis reported with
the use of Triclosan.
4.9 OVERDOSE