STERETS TISEPT SACHETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CETRIMIDE; CHLORHEXIDINE DIGLUCONATE

Available from:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC code:

D08AC52

Pharmaceutical form:

SOLUTION

Composition:

CETRIMIDE 0.15 %W/V; CHLORHEXIDINE DIGLUCONATE 0.015 %W/V

Administration route:

CUTANEOUS

Prescription type:

Not required

Manufactured by:

MEDLOCK MEDICAL LIMITED, UK

Therapeutic area:

CHLORHEXIDINE, COMBINATIONS

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

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® TISEPT SACHETS
CUTANEOUS SOLUTION
CHLORHEXIDINE GLUCONATE 0.015% W/V / CETRIMIDE 0.15% 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 Tisept 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, Cetrimide 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.
- In the internal cavities of the body.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
-Talk to your doctor or nurse before using Sterets Tisept 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 Tisept 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 Tisept may cause
chemical skin burns.
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY
TAKEN ANY OT

Summary of Product characteristics

STERETS TISEPT SACHETS
PHYSICIAN'S LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
Sterets Tisept Sachets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 0.015% w/v
(incorporated as 20% w/v Chlorhexidine gluconate Solution)
Cetrimide 0.15% w/v
3.
PHARMACEUTICAL FORM
Cutaneous 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
Cutaneous.
Use 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 Tisept should not come into contact with the brain, eyes,
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 excessive
quantities and do not allow the solution to pool in skin folds or
under the patient or drip on sheets or other
ma