Sterets Unisept 0.05% w/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorhexidine gluconate

Available from:

Medlock Medical Ltd

ATC code:

D08AC; D08AC02

INN (International Name):

Chlorhexidine gluconate

Dosage:

0.05 percent weight/volume

Pharmaceutical form:

Cutaneous solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Biguanides and amidines; chlorhexidine

Authorization status:

Marketed

Authorization date:

1988-05-30

Patient Information leaflet

Sterets
®
Unisept
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STERETS UNISEPT 0.05% W/V CUTANEOUS SOLUTION
Chlorhexidine gluconate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE
ADMINISTERED THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• Ask your doctor or nurse if you need more
information or advice.
•
talk to your doctor
WHAT IS IN THIS LEAFLET
1. WHAT STERETS UNISEPT IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE STERETS
UNISEPT IS USED
3. HOW STERETS UNISEPT WILL BE USED
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE STERETS UNISEPT
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT STERETS
UNISEPT
IS
AND
WHAT IT IS
USED FOR
Sterets Unisept is a sterile, pink, cutaneous
solution containing Chlorhexidine gluconate,
which has antiseptic properties
(that is, it kills germs).
Sterets Unisept is used to help prevent infection
from occurring during and after childbirth, and
also in wounds and burns.
2. WHAT YOU NEED TO KNOW BEFORE STERETS
UNISEPT IS USED
DO NOT USE STERETS UNISEPT:
• if you are allergic to Chlorhexidine gluconate or
to any of the other ingredients of this medicine
(listed in section 6). If you are not sure if this
applies to you, talk to your doctor or nurse
before this medicine is used.
• if the product could come into contact with the
brain, meninges (the membranes surrounding
the brain and spinal cord) or the inside of
the ear.
• inside the body’s internal spaces.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before Sterets
Unisept is used.
• Avoid contact with the eyes and ears.
• Common bleaches (which contain
hypochlorites) may cause brown stains to
develop in fabrics which have previously been
in contact with Sterets
Unisept solution.
• The product’s action may be reduced if used
with soap or detergents.
OTHER MEDICINES AND STER
ETS UNISEPT
Tell your doctor or nurse if you are using, have
recently used or might use any other medicines.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If

Summary of Product characteristics

Health Products Regulatory Authority
15 October 2019
CRN00919J
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterets Unisept 0.05% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 0.05 % w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
A clear, pink sterile cutaneous solution contained within a
colourless, plastic sachet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chlorhexidine gluconate is a potent antibacterial agent for general
antiseptic purposes. It is bactericidal to a broad spectrum of
organisms. Sterets Unisept is recommended for use in obstetrics and
for swabbing burns and wounds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous application.
There is no distinction between adults, children or the elderly.
Sterets Unisept should be used without further dilution for
topical administration only.
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).
Sterets Unisept should not come into contact with brain, meninges or
middle ear.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Sterets Unisept 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 Unisept 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 we