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Meda Pharmaceuticals
Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU Telephone: 0845 460 0000 Fax: 0845 460 0002 Medical Information Direct Line: +44 (0)1748 828 810 Medical Information e-mail: meda@professionalinformation.co.uk Medical Information Fax: +44 (0)1748 828 801 Out of Hours e-mail: +44 (0)1748 828 810 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 08/12/2006

SPC

Ultrabase

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Ultrabase®

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

There are no active constituents.

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3. PHARMACEUTICAL FORM

Cream

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For general use as:

- an emollient

- a diluent for dermatological preparations and

- a vehicle for various dermatological medicaments.

Additionally, it may be alternated with topical corticosteroids when the latter are being gradually withdrawn, and may be continued alone after complete withdrawal of the topical corticosteroid.

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4.2 Posology and method of administration

For topical administration as required.

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4.3 Contraindications

Hypersensitivity to any of the components of Ultrabase.

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4.4 Special warnings and precautions for use

None stated.

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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4.6 Pregnancy and lactation

None stated.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

None known.

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4.9 Overdose

Not applicable. Ultrabase contains no active ingredients.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Ultrabase has no specific active ingredient, but the cream formulation has good emollient properties.

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5.2 Pharmacokinetic properties

None stated.

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5.3 Preclinical safety data

There are no preclinical safety data which could be of relevance to the prescriber and which are not already included in other relevant sections of the SPC.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Polyoxyl 40 stearate [E431]

White soft paraffin

Liquid paraffin

Stearyl alcohol

Carbomer

Sodium hydroxide

Methyl parahydroxybenzoate (methyl paraben) [E218]

Propyl parahydroxybenzoate (propyl paraben) [E216]

Disodium edentate [E463]

Purified water

Citrus-rose perfume oil

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6.2 Incompatibilities

None known.

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6.3 Shelf life

5 years.

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6.4 Special precautions for storage

Not applicable.

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6.5 Nature and contents of container

This product is available in collapsible aluminium tubes (10 g or 50 g) and polypropylene jars (500 g). Also available in polypropylene pump dispensers (500 g).

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6.6 Special precautions for disposal and other handling

Keep out of the reach of children.

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7. MARKETING AUTHORISATION HOLDER

Intendis GmbH

Max-Dohrn-Strasse 10

D-10589

Berlin

Germany

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8. MARKETING AUTHORISATION NUMBER(S)