DITHROCREAM Cream (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Dithrocream 0.1%.
2. Qualitative and quantitative composition
Dithranol EP 0.1% w/w. For excipients, see 6.1.
3. Pharmaceutical form
Yellow aqueous cream.
4.1. Therapeutic indications
For the topical treatment of subacute and chronic psoriasis including psoriasis of the scalp.
4.2. Posology and method of administration
Dithranol therapy customarily involves titrating the concentration applied to skin to suit individual patients circumstances. Dithrocream is, therefore, available in five strengths. The different packs ...
4.3. Contraindications
Not to be used on the face, or for acute or pustular psoriasis. Not to be used in cases of sensitivity to any of the ingredients.
4.4. Special warnings and precautions for use
Dithrocream 0.5%, Dithrocream 1.0% and Dithrocream 2.0% should only be used for those patients who have failed to respond to lower strengths of dithranol. Dithrocream 1.0% and 2.0% should normally only ...
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
Although there is no experimental evidence to support the safety of the drug in pregnancy or during lactation, no adverse effects have been reported.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Some skin irritation and/or a feeling of warmth at the site of application is normally associated with dithranol therapy. Dithrocream applied at too high a strength or left in contact with the skin for ...
4.9. Overdose
Dithranol is a cathartic (laxative) and if accidentally swallowed, it should be removed by gastric lavage.
5.1. Pharmacodynamic properties
Dithranol has been used in the treatment of sub-acute and chronic psoriasis for over 70 years and, during that time it has become established as a safe and effective form of therapy. Its precise mode of ...
5.2. Pharmacokinetic properties
The traditional formulations of dithranol are based on soft paraffin from which it is effectively released into the skin. In Dithrocream, during manufacture, the oily paraffin phase of the cream is heated ...
5.3. Preclinical safety data
No special information.
6.1. List of excipients
White soft paraffin Cetostearyl alcohol Salicylic acid Ascorbic acid Sodium laurilsulfate Chlorocresol Purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
48 months.
6.4. Special precautions for storage
Do not store above 25°C. Replace cap tightly after use.
6.5. Nature and contents of container
50 g and 100 g membrane-sealed, epoxy resin-coated aluminium collapsible tubes with high density polyethylene white spiked screw caps, supplied as original packs (OP).
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Diomed Developments Ltd, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
8. Marketing authorization number(s)
PL 00173/0029
9. Date of first authorization / renewal of the authorization
17 February 1978 / 31 July 2008 for 16/02/08 renewal date (unlimited validity granted)
10. Date of revision of the text
03/07/2015
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