STERETS UNISEPT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CHLORHEXIDINE DIGLUCONATE

Available from:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC code:

D08AC02

Pharmaceutical form:

SOLUTION

Composition:

CHLORHEXIDINE DIGLUCONATE 0.05 %W/V

Administration route:

CUTANEOUS

Prescription type:

Not required

Manufactured by:

MEDLOCK MEDICAL LIMITED, UK

Therapeutic area:

CHLORHEXIDINE

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.

Authorization date:

2016-06-08

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS), 1986.
This medicine is dispensed without a doctor’s prescription.
STERETS® UNISEPT
CUTANEOUS SOLUTION
CHLORHEXIDINE GLUCONATE 0.05% W/V
For the list of inactive ingredients see section 6.
CAREFULLY READ THE ENTIRE LEAFLET BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about the medicine. If you have further questions, refer to your
doctor or pharmacist.
This medicine was prescribed to you. Do not pass it on to others. It
may harm them, even if it seems that
they have a similar medical condition.
Use the medicine correctly. Ask your doctor if symptoms worsen or do
not improve.
The medicine is intended for adults and children.
1. WHAT IS THE MEDICINE INTENDED FOR?
Sterets Unisept sachets are used to help prevent infection from
occurring during and after childbirth,
and also in wounds and burns.
THERAPEUTIC GROUP:
Antiseptic solution.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE:
-
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
using this medicine.
-
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.
-
In the internal cavities of the body.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
- Talk to your doctor or nurse before using Sterets Unisept sachets.
- Avoid contact with the eyes and ears.
- Household bleaches (which contain hypochlorites) may cause brown
stains to appear on fabrics that
have had contact with Sterets Unisept solution.
- The product's effectiveness may be impaired if used with soap or
detergents.
CHILDREN
Use with care in newborn babies, especially those born prematurely.
Sterets Unisept solution may cause
chemical skin burns.
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY
TAKEN ANY OTHER
MEDICINES, INCLUDING N

Summary of Product characteristics

STERETS UNISEPT
PHYSICIAN'S LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
Sterets Unisept.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate Solution 20% w/v 0.05% w/v.
3.
PHARMACEUTICAL FORM
Sterile Aqueous Solution.
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
Cutaneous.
There is no distinction between adults, the elderly and children.
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 the 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 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
excessive quantities and do not allow the solution to pool in skin
folds