Sterets Tisept Sachets 0.015% w/v and 0.15% w/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorhexidine gluconate; Cetrimide

Available from:

Medlock Medical Ltd

ATC code:

D08AC52

INN (International Name):

Chlorhexidine gluconate; Cetrimide

Dosage:

0.015 %w/v + 0.15 percent volume/volume

Pharmaceutical form:

Cutaneous solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

chlorhexidine, combinations

Authorization status:

Marketed

Authorization date:

1988-05-30

Patient Information leaflet

PANTONE Cool Gray 10 U
PANTONE 361 U
Profile
Medlock
Tisept Leaflet
327193-01
504000.209x144.004
Rachel Webb
12/02/15
MB
XX
XX
XX
XX
X
X
X
X
X
XX
XX
XX
XX
XX
X
X
X
X
209 x 144
01
MetalBack Ref
Emboss Ref
PANTONE Cool Gray 10 U
PANTONE 361 U
Profile
Medlock
Tisept Leaflet
327193-01
504000.209x144.004
Rachel Webb
12/02/15
MB
XX
XX
XX
XX
X
X
X
X
X
XX
XX
XX
XX
XX
X
X
X
X
209 x 144
01
MetalBack Ref
Emboss Ref

Summary of Product characteristics

Health Products Regulatory Authority
23 August 2019
CRN00919G
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterets Tisept Sachets 0.015% w/v and 0.15% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 0.015 % w/v
Cetrimide 0.15 % w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A clear, yellow, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A broad spectrum antiseptic with detergent properties for swabbing in
obstetrics and during dressing changes. For
disinfecting and cleansing traumatic and surgical wounds and burns.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical application.
Cleanse affected area or involved skin with undiluted preparation.
4.3 CONTRAINDICATIONS
1. 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).
2. Use in contact with brain, meninges or middle ear.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Sterets Tisept Sachets contains chlorhexidine. Chlorhexidine is known
to induce hypersensitivity, including generalised allergic
reactions and anaphylactic shock. The prevalence of chlorhexidine
hypersensitivity is not known, but available literature
suggests this is likely to be very rare. Sterets Tisept Sachets should
not be administered to anyone with a potential history of an
allergic reaction to a chlorhexidine-containing compound (see sections
4.3 and 4.8).
The use of chlorhexidine solutions, both alcohol based and aqueous,
for skin antisepsis prior to invasive procedures has been
associated with chemical burns in neonates. Based on available case
reports and the published literature, this risk appears to be
higher in preterm infants, especially those born before 32 weeks of
gestation and within the first 2 weeks of life.
Remove any soaked materials, drapes or gowns before proceeding with
the intervention. Do not use excess