Saturday, May 19, 2012

CX Powder (Ecolab)





1. Name Of The Medicinal Product



CX POWDER


2. Qualitative And Quantitative Composition



Chlorhexidine Acetate BP 1% w/w



3. Pharmaceutical Form



Powder



4. Clinical Particulars



4.1 Therapeutic Indications



General skin disinfection and antisepsis for topical application only.



4.2 Posology And Method Of Administration



Apply lightly to the affected area up to three times daily. The dosage schedule does not require adjustment for adults, children or the elderly. The dosage is as stated for both the clinical indications, vis skin disinfection and antisepsis.



4.3 Contraindications



Known hypersensitivity to chlorhexidine.



4.4 Special Warnings And Precautions For Use



Skin sensitivity to Chlorhexidine salts has occurred occasionally, Chlorhexidine salts are irritant to the conjunctiva and other sensitive tissue.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known



4.6 Pregnancy And Lactation



No special precautions need to be taken when used in pregnancy and lactation.



4.7 Effects On Ability To Drive And Use Machines



None known



4.8 Undesirable Effects



None known



4.9 Overdose



Not applicable. Ingestion of Chlorhexidine salts should be treated symptomatically, unless gastric lavage is required from other clinical considerations.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Chlorhexidine Acetate is an antibacterial substance which is effective against a wide range of gram-positive and gram-negative bacteria. It has limited activity against some viruses and fungi. It is inactive against bacterial spores at room temperature and some strains of pseudomonas and proteus tend to be less susceptible than other bacteria.



Sterilisable Maize Starch BP is an absorbent powder.



5.2 Pharmacokinetic Properties



Not applicable. The product is for topical application and significant systematic absorption does not occur.



5.3 Preclinical Safety Data



None stated



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sterilisable Maize Starch BP.



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



2 years



6.4 Special Precautions For Storage



Store below 25°C. Protect from light.



6.5 Nature And Contents Of Container



CX Powder is packed in LDPE bottles fitted with a nozzle plug and white plastic cap. Pack size 15g.



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.



8. Marketing Authorisation Number(S)



PL 04509/0011



9. Date Of First Authorisation/Renewal Of The Authorisation



05/12/2008



10. Date Of Revision Of The Text



05/12/2008




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