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STERETS TISEPT SACHETS

Active substance(s): CETRIMIDE / CHLORHEXIDINE GLUCONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sterets Tisept Sachets.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate Solution 20% w/v
Cetrimide

3.

0.015%w/v
0.15%w/v

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 material in direct contact with the patient. Where occlusive
dressings are to be applied to areas previously exposed to Sterets Tisept Sachets, care must be
taken to ensure no excess product is present prior to application of the dressing.
For external use only. Not for injection. When used in aseptic procedures, the outside of the
sachet should be disinfected before opening. Discard any surplus immediately after use. Do
not use within body cavities.

4.5.

Interactions with other medicinal products and other forms of interaction
Hypochlorite bleaches may cause brown stains to develop in fabrics which
have previously been in contact with Sterets Tisept solution.

4.6.

Pregnancy and lactation
Although there are no adverse reports for this product in pregnant and
lactating mothers, as with all medicines, care should be exercised when
administering the product to pregnant or lactating women.

4.7.

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects

Very Common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, <
1/100); Rare (≥ 1/10,000, < 1/1,000); Very rare (< 1/10,000); not known (cannot be
estimated from the available data).

Skin and subcutaneous tissue disorders:
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema,
eczema, rash, urticaria, skin irritation, and blisters.
Immune system disorders:
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3
and 4.4).
Injury, poisoning and procedural complications:
Frequency not known: Chemical burns in neonates
In addition, cetrimide has been reported to cause dry skin and in rare cases chemical
burn after repeated application.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9.

Overdose
Accidental ingestion: Gastric lavage should be carried out with milk, egg
white, gelatine or mild soap.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Chlorhexidine is a disinfectant which is effective against a wide range of
vegetative gram-positive and gram-negative bacteria ; it is more effective
against gram-positive than gram-negative bacteria, some species of
Pseudomonas and Proteus being less susceptible. The wide range of
organisms against which Chlorhexidine is active explains the rationale for
presenting it in a solution for swabbing wounds and burns and in obstetrics.
Cetrimide is a quaternary ammonium disinfectant with properties and uses
typical of cationic surfactants. It is used in Sterets Tisept antiseptic for its
surfactant and bactericidal properties.

5.2

Pharmacokinetic properties

The BP 1993 contains monographs for both Chlorhexidine Gluconate solution
20% w/v and Cetrimide. The pharmacokinetics of the compounds when
applied to the skin are well described in the literature.

5.3

Pre clinical safety data
Not applicable.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Purified Water
Sunset Yellow E110
Sodium Hydroxide.

6.2.

Incompatibilities
Sterets Tisept is incompatible with anionic agents.

6.3.

Shelf life
36 months unopened.

6.4

Special precautions for storage

Do not store above 25ºC. Store in the original package.
6.5

Nature and contents of container
Nylon/ethylene propylene copolymer laminate sachets overwrapped in heat
sealed polythene/nylon and/or polythene/polyester pouches.
Pack sizes; 25ml and 100ml.

6.6

Special precautions for disposal

Not applicable.

7.

MARKETING AUTHORISATION HOLDER
Medlock Medical Ltd
Tubiton House
Oldham
OL1 3HS
England.

8.

MARKETING AUTHORISATION NUMBER
PL 21248/0035

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/04/1987 / 08/11/2004

10

DATE OF REVISION OF THE TEXT
10/12/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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