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

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Chlorhexidine gluconate; Cetrimide

Commercializzato da:

Medlock Medical Ltd

Codice ATC:

D08AC52

INN (Nome Internazionale):

Chlorhexidine gluconate; Cetrimide

Dosaggio:

0.015 %w/v + 0.15 percent volume/volume

Forma farmaceutica:

Cutaneous solution

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

chlorhexidine, combinations

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1988-05-30

Foglio illustrativo

PANTONE Cool Gray 10 U
PANTONE 361 U
Profile
Medlock
Tisept Leaflet
327193-01
504000.209x144.004
Rachel Webb
12/02/15
MB
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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

Scheda tecnica

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