Sterexidine 5000 Solution 0.02% W/V
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterexidine 5000 Solution 0.02%w/v
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient:
Chlorhexidine Gluconate Solution 20% BP equivalent to: Chlorhexidine Gluconate 0.02%w/v
3. PHARMACEUTICAL FORM
Sterile fluid.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Chlorhexidine is recommended for disinfection and wound cleansing.
The l00ml PVC presentation is suitable for use as a bladder irrigation; aqueous chlorhexidine is effective against a wide range of urinary tract pathogens.
4.2. Posology and Method of Administration
By irrigation.
Adults, the elderly and children: As determined by the clinician.
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).
Avoid contact with eyes, brain, meninges, middle ear or external ear with perforated tympanic membrane. Not for intravenous administration.
4.4 Special warnings and precautions for use
Sterexidine 5000 Solution 0.02%w/v 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 rare. Sterexidine 5000 Solution 0.02% w/v should not be administered to anyone with a potential history of an allergic reaction to 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 Sterexidine 5000 Solution 0.02% w/v, care must be taken to ensure no excess product is present prior to application of the dressing.
Do not use unless the solution is clear and the container is intact. Discard any unused contents.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
None stated.
4.6 Pregnancy and Lactation
Use in pregnancy is not considered a hazard.
4.7. Effects on Ability to Drive and Use Machines
Does not affect the ability to drive or operate machinery.
4.8 Undesirable effects Skin Disorders
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation and blisters.
Immune Disorders
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
Chemical Burns in Neonates
Frequency unknown.
When used for bladder irrigation, chlorhexidine solutions may irritate the mucosa and cause burning and haematuria (in which case they should be discontinued).
4.9. Overdose
Chlorhexidine is poorly absorbed from the gastro-intestinal tract. Haemolysis has been reported following ingestion or accidental intravenous administration. Acute ingestion may require gastric lavage with demulcents. Haemolysis may necessitate blood transfusion.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Chlorhexidine is a bisbiguanide antiseptic and disinfectant which is bactericidal or bacteriostatic against a wide range of Gram-positive and Gramnegative bacteria. It is more effective against Gram-positive than Gramnegative bacteria, some species of pseudomonas and proteus being less susceptible. Chlorhexidine inhibits mycobacteria, some viruses and is active against some fungi. It is inactive against bacterial spores at room temperature.
5.2 Pharmacokinetic Properties
Chlorhexidine is poorly absorbed from the gastro-intestinal tract and skin.
5.3 Preclinical Safety Data
None stated
PHARMACEUTICAL PARTICULARS
6.
6.1. List of Excipients
Water for Injections BP.
6.2. Incompatibilities
Chlorhexidine salts are incompatible with soaps and other anionic materials.
6.3. Shelf-Life
24 months from the date of manufacture.
6.4. Special Precautions for Storage
Protect from light.
Store between 50C and 250C.
6.5. Nature and Contents of Container
Polypropylene containers.
Pack sizes: 150m1, 500m1 and 1000ml.
PVC which complies with EP VI 2.2.3 1990 (Containers for intravenous infusion).
Closures:
(a) radiofrequency weld
(b) polycarbonate plug
(c) PVC plug Pack size: 100ml.
6.6. Instruction for Use, Handling and Disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Terumo BCT Ltd.
Old Belfast Road
Millbrook
Larne
Northern Ireland BT40 2SH United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 21538/0015
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
12th April 2005
10 DATE OF REVISION OF THE TEXT
19/05/2015