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STERETS UNISEPT

Active substance(s): CHLORHEXIDINE GLUCONATE SOLUTION 20%

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SUMMARY OF PRODUCT CHARACTERISTICS

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 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 Unisept, 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 Sterets Unisept is used in aseptic
procedures, the outside of the sachet should be disinfected before opening. Discard
any surplus immediately after use. Contact with eyes should be avoided. Do not use
within body cavities.
4.5
Interaction 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 Unisept solutions.
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
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 or search for MHRA Yellow Card in the
Google Play or Apple App Store
4.9
Overdose
Treatment
Accidental ingestion: Gastric lavage should be carried out with milk, egg
white, gelatine or mild soap.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: antiseptics and disinfectants, ATC code: D08AC02
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.
5.2
Pharmacokinetic properties
The BP 1993 contains a monograph for Chlorhexidine Gluconate Solution
20% w/v. The pharmacokinetics of the compound when applied to the skin as
a topical antiseptic are well understood and described in the literature.
5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Cocamidopropyl Betaine, Carmoisine Red (E122), purified water, sodium hydroxide
(for pH-adjustment).
6.2
Incompatibilities
Sterets Unisept 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 containing either 25 ml
or 100 ml of product overwrapped in heat sealed polythene/nylon and / or
polythene/polyester pouches.

6.6

Special precautions for disposal
Not applicable.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 21248/0037

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

24/04/1987 / 08/11/2004

10

DATE OF REVISION OF THE TEXT
15/11/2017

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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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