STERETS UNISEPT Cutaneous solution (2019)
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Περιεχόμενα
1. Name of the medicinal product
Sterets Unisept 0.05% w/v Cutaneous Solution.
2. Qualitative and quantitative composition
Chlorhexidine Gluconate 0.05 % w/v. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous solution. A clear, pink sterile cutaneous solution contained within a colourless, plastic sachet.
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 ...
4.2. Posology and method of administration
For cutaneous application. There is no distinction between adults, children or the elderly. 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 ...
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 ...
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 solution. Sterets Unisept is incompatible with anionic agents.
4.6. Fertility, 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 ...
4.9. Overdose
Accidental ingestion: Gastric lavage should be carried out with milk, egg white, gelatine or mild soap.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antiseptics and disinfectants <b>ATC code:</b> D08AC02 Chlorhexidine is a disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative ...
5.2. Pharmacokinetic properties
The BP 1993 contains a monograph for chlorhexidine gluconate. The pharmacokinetics of the compounds when applied to the skin as a topical antiseptic are well described in the literature.
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Purified Water Nonoxinol 9 Carmoisine Red (E122) Sodium Hydroxide (for pH-adjustment)
6.2. Incompatibilities
Sterets Unisept is incompatible with anionic agents.
6.3. Shelf life
18 months. Once opened use immediately and discard any unused portion.
6.4. Special precautions for storage
Do not store above 25°C. Store sachets in outer container (plastic pouch).
6.5. Nature and contents of container
25 ml or 100 ml in polyamide/polypropylene copolymer laminate sachets in a polythene/polyamide pouch. <u>Pack sizes:</u> Pouch containing 25 25 ml sachets or 10 100 ml sachets. Not all pack sizes may ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Medlock Medical Ltd, Tubiton House, Medlock Street, Oldham, OL1 3HS, United Kingdom
8. Marketing authorization number(s)
PA1175/015/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 30th May 1988 Date of last renewal: 30th May 2008
10. Date of revision of the text
October 2019
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