BETNESOL Solution for injection Ref.[11082] Active ingredients: Betamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden

Product name and form

Betnesol 4mg/ml Solution for injection.

Betamethasone 4mg/ml Solution for injection.

Pharmaceutical Form

Solution for injection.

1ml ampoules containing a clear colourless or pale yellow solution.

Qualitative and quantitative composition

Each ampoule contains 5.3mg of betamethasone sodium phosphate equivalent to 4mg betamethasone in 1ml of sterile aqueous solution.

Excipients with known effect: Sodium Metabisulphite contains 0.100% w/v

Also contains approximately 0.678mg sodium per ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Betamethasone

Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. Betamethasone has anti-inflammatory, antipruritic, and vasoconstrictive properties.

List of Excipients

Disodium edetate
Sodium metabisulphite
Sodium chloride
Sodium hydroxide
Hydrochloric acid
Water for injection

Pack sizes and marketing

1ml clear, one-point cut (OPC) colourless glass Type 1 Ph Eur ampoules packed in cartons of 5 ampoules.

Marketing authorization holder

RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden

Marketing authorization dates and numbers

PL 36301/0054

22nd December 1992

Drugs

Drug Countries
BETNESOL Canada, France, Ireland, Israel, Netherlands, United Kingdom

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