Hydrogen Peroxide Solution 6% (20 Vol) B.P.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrogen Peroxide 6% (20 Vol) BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrogen Peroxide BP 6% w/v
3 PHARMACEUTICAL FORM
Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Used as a gargle or mouthwash and for the treatment of cuts, wounds and abrasions.
4.2 Posology and method of administration
As a gargle or mouthwash (DO NOT SWALLOW):
For adults, including the elderly & children over 8: Use one dessert spoonflul in half tumbler of water.
For the treatment of cuts, wounds & abrasions (DO NOT USE UNDILUTED AS IRRITATING BURNS OF THE SKIN. MOUTH OR EYES MAY RESULT):
For adults, including the elderly & children: Dilute with an equal quantity of water. Apply to the dressing and leave to soak before positioning on the wound. Affix with a bandage or sticking plaster.
4.3 Contraindications
None Stated
4.4 Special warnings and precautions for use
For external use only. Store in a cool place protected from direct sunlight.
4.5 Interaction with other medicinal products and other forms of interaction
Hydrogen Peroxide is a powerful oxidising agent.
4.6 Fertility, Pregnancy and lactation
Acceptable for use during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
None Stated
4.9 Overdose
If used undiluted this product could produce irritating “burns” on the skin and mucous membranes with a white eschar. Continued use of hydrogen peroxide as a mouthwash may cause reversible hypertrophy of the papillae of the tongue. In either case cessation of the use of the peroxide will allow natural regeneration of the tissues. For serious “burns” the appropriate “burns therapy” should be used.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Hydrogen Peroxide readily releases oxygen when applied to tissues. As the oxygen is released dead tissue and pockets of bacteria are detached, even from inaccessible parts.
5.2 Pharmacokinetic properties
The effervesence produced when the product comes into contact with the tissues detaches the dead skin and bacteria. These can then be washed off the skin
5.3 Preclinical safety data
None Stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Unspecified stabilisers to 0.025%w/v Water to 100.0% v/v
6.2 Incompatibilities
Incompatible with reducing agents including:
Organic matter and oxidisable substances and with alkalis, iodides, permanganates, and other stronger oxidising agents. Its decomposition is increased by metallic salts, light agitation and heat, as well as by metals. It is compatively stable in the presence of a slight excess of acid. Hydrogen peroxide could interfere with the Clinitest and Labstix qualitative urine tests for glucose to produce false positivce results.
6.3 Shelf life
3 Years
6.4 Special precautions for storage
Store in a cool dry place.
Protect from direct sunlight
6.5 Nature and contents of container
Opaque containers and lids 100ml, 1 75m1. 200m1 and 2000m1
6.6 Special precautions for disposal
None Stated
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
PC. 1060 Nicosia.
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0135
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/02/2009
10 DATE OF REVISION OF THE TEXT
10/10/2013