Tuesday, October 25, 2016

Ceanel Concentrate (Ferndale Pharmaceuticals Ltd)





1. Name Of The Medicinal Product



Ceanel Concentrate


2. Qualitative And Quantitative Composition








Cetrimide BP




10.0%w/v




Undecenoic Acid BP




1.0%v/v



For full list of excipients, see Section 6.1.



3. Pharmaceutical Form



Ceanel Concentrate is a clear, viscous, golden-yellow coloured liquid.



4. Clinical Particulars



4.1 Therapeutic Indications



As an adjunct in the management psoriasis of the scalp, seborrhoeic dermatitis, dandruff-psoriasis of the trunk and limbs.



4.2 Posology And Method Of Administration



For topical use only.



Adults, Children and the Elderly:



Scalp Conditions:



Wet the scalp and hair with warm water. Protect the eyes with a towel to avoid discomfort. Apply ½ - 1 teaspoonful of Ceanel to the wetted scalp. Then apply a small amount of water and work up into lather. Rinse and repeat. Finally rinse the hair and scalp thoroughly. Use three times in the first week and twice weekly thereafter.



Other areas of the body.



Wet the area to be treated with warm water; apply sufficient Ceanel Concentrate by gentle massage to cover the wetted area. Allow to remain in contact for two minutes. Remove the Ceanel by thorough rinsing with warm water. Use as required.



4.3 Contraindications



Hypersensitivity to one of the ingredients.



4.4 Special Warnings And Precautions For Use



In common with other shampoos, it is suggested that the eyes be closed during treatment to avoid discomfort or that they may be protected with a towel.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



There is inadequate evidence of safety in human pregnancy, but it has been in wide use for many years without apparent ill consequence. As with other medicaments it may be used during pregnancy if the anticipated benefits outweigh the risks. No problems are anticipated during lactation.



4.7 Effects On Ability To Drive And Use Machines



Not applicable.



4.8 Undesirable Effects



None known.



4.9 Overdose



Ceanel Concentrate is for external use only. Following accidental ingestion, nausea and vomiting may occur as well as respiratory problems and hypotension. Treatment is supportive and symptomatic avoiding gastric lavage.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Cetrimide is particularly active against Gram-positive organisms. This feature combined with the flingicidal properties of undecenoic acid makes Ceanel Concentrate particularly effective in the treatment of dermatological conditions. Ceanel Concentrate is effective in removing debris and scale in seborrhoea capitis and psoriasis of the scalp.



5.2 Pharmacokinetic Properties



Not applicable.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Phenylethyl Alcohol, Lauric Diethanolamide, Diethanolamine, Poly Oxy Propylene Stearyl Ether, Purified Water BP.



6.2 Incompatibilities



None known



6.3 Shelf Life



3 years



6.4 Special Precautions For Storage



Ceanel Concentrate should be stored in a cool, dry place avoiding extremes of temperature i.e. not less than 5oC and not more than 30oC.



6.5 Nature And Contents Of Container



Ceanel Concentrate is available in polyethylene bottles with a screw top containing 50ml, 150ml, 500ml. The 50ml presentation is cartooned and contains a patient information leaflet.



6.6 Special Precautions For Disposal And Other Handling



No special instructions.



7. Marketing Authorisation Holder



Ferndale Pharmaceuticals Ltd



12 York Place



Leeds



LS1 2DS



United Kingdom



8. Marketing Authorisation Number(S)



PL 20685/0006



9. Date Of First Authorisation/Renewal Of The Authorisation



1 January 2004



10. Date Of Revision Of The Text



7 October 2010



11 DOSIMETRY


(IF APPLICABLE)



12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS


(IF APPLICABLE)




No comments:

Post a Comment