Summary of Product Characteristics (SmPC) - Prevase Chlorhexidine Gluconate 0.5% w/v in 70% v/v Deb cutaneous solution
1 NAME OF THE MEDICINAL PRODUCT
Prevase Chlorhexidine Gluconate 0.5% w/v in 70% v/v DEB Cutaneous Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate Solution 20% BP (Ph Eur) 2.5% v/v
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For pre-operative skin disinfection prior to minor surgical procedures.
4.2 Posology and method of administration
This product is applied topically. For single use only.
4.3 Contraindications
Do not use in patients with a 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).
Do not use in contact with eyes, brain, meninges, middle ear or external ear with a perforated tympanic membrane.
Do not inject.
When use is to be followed by diathermy do not allow pooling of the fluid to occur and ensure that the skin and surrounding drapes are dry. Do not use in body cavities.
4.4 Special warnings and precautions for use
Prevase 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. Prevase should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see section 4.3 and 4.8).
Accidental ingestion:- chlorhexidine is poorly absorbed orally. Treat with gastric lavage using milk, egg white, gelatine or mild soap. Employ supportive measures as appropriate.
Accidental intravenous infusion – blood transfusion may be necessary to counteract haemolysis.
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, the 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 of sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Prevase, care must be taken to ensure no excess product is present prior to application of the dressing.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, pregnancy and lactation
None stated.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Immune disorders
Frequency not known:
Hypersensitivity including anaphylactic shock (see sections 4.3 and
4.4).
Skin disorders
Frequency not known:
- Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticarial, skin irritation, and blisters.
- Chemical burns in neonates and infants
System organ class | Very common (≥1/10) | Common (≥1/100 <1/10) | Uncommon (≥1/10,000 <1/1,000) | Rare (≥1/10,000 <1/1,000) | Very rare (<1/10,000) | Not known | ||
| (cannot be | ||||||||
| estimated from | ||||||||
| available data) | ||||||||
Immune system disorders | Hypersensitivity Anaphylactic shock | |||||||
Skin and subcutaneous tissue disorders | Allergic skin reactions Chemical burns (neonates and infants) | |||||||
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 the 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
None stated
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
None stated
5.2 Pharmacokinetic properties
None stated
5.3 Preclinical safety data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Denatured Ethanol B 96%
Purified Water
111959 Carmoisine (E122)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Prevase is packaged in a 200ml natural round HDPE bottle with a white PP and PE screw cap closure.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Ecolab Ltd,
Lotherton Way,
Garforth, Leeds,
LS25 2JY.
8 MARKETING AUTHORISATION NUMBER(S)
PL 04509/0062
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/08/2018
10 DATE OF REVISION OF THE TEXT
05/10/2021