Carbo-Dome Cream (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Sandoz Limited |
|---|---|
| Διεύθυνση | 200 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK |
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Name of the medicinal product
Carbo-Dome Cream.
Qualitative and quantitative composition
Each 100g of cream contains coal tar solution BP 10g. For a full list of excipients, see section 6.1.
Pharmaceutical form
Cream.
Therapeutic indications
The coal tar solution in Carbo-Dome Cream has a keratoplastic and antipruritic effect in psoriasis. Indications: Psoriasis.
Posology and method of administration
For topical application only. Adults and children over 12 years of age: Ensure that the lesions are clean. Apply a thin layer of Carbo-Dome Cream two or three times a day on to the affected areas massage ...
Contraindications
Coal tar should not be used when a patient has known sensitivity to coal tar or any of the other ingredients. If you have folliculitis and acne vulgaris. Carbo-Dome Cream should not be used on patients ...
Special warnings and precautions for use
For topical administration only. Coal tar may cause skin irritation, should this occur the treatment should be reviewed and if necessary discontinued. Coal tar enhances photosensitivity of the skin after ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
There is no direct evidence of the safety in pregnant and lactating women but coal tar preparations have been in use for many years without apparent ill-consequence and no harmful effects on the health ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Skin and subcutaneous tissue disorders: Skin irritation, photosensitivity of the skin, coal tar may cause acne-like eruptions of the skin. There is an increased risk of skin cancer in psoriatic patients ...
Overdose
There is no evidence that an overdose of topical Carbo-Dome Cream would be harmful other than a hypersensitivity to coal tar. Ingestion of Carbo-Dome Cream may require gastric lavage depending on the quantity ...
Pharmacodynamic properties
Carbo-Dome Cream contains coal tar an antipruritic and keratoplastic. Its used in the treatment eczema, psoriasis and other skin conditions. Tar acids have also been shown to have disinfectant properties. ...
Pharmacokinetic properties
The product is designed for external use only. Absorption of the coal tar is not reported in Martindale and therefore the pharmacokinetics is not addressed.
Preclinical safety data
In animal studies on coal tar has an increase in incidence of epidermal carcinomas and self-limiting keratoacanthomas. While the ingredients of coal tar have been shown to express genotoxic properties, ...
List of excipients
Dehydag wax SX Beeswax White soft paraffin Light liquid paraffin Glycerol Sodium lauryl sulphate Methyl-p-hydroxybenzoate Purified water
Incompatibilities
None recorded.
Shelf life
36 months.
Special precautions for storage
Store in a cool place.
Nature and contents of container
Tubes (aluminium). Pack sizes: 30g and 100g.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Sandoz Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom
Marketing authorization number(s)
PL 04416/0106
Date of first authorization / renewal of the authorization
12 February 1986
Date of revision of the text
March 2011