PROTIUM Powder for solution for injection Ref.[49956] Active ingredients: Pantoprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom

Product name and form

Protium i.v. 40 mg powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection.

White to off-white powder.

Qualitative and quantitative composition

Each vial contains 40 mg of pantoprazole.

Excipients with known effect:

Each vial contains 1 mg disodium edetate and 0.24 mg sodium hydroxide.

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially ‘sodium-free’.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Pantoprazole

Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.

List of Excipients

Disodium edetate
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

10 ml clear glass (type I) vial with aluminium cap and grey rubber stopper containing 40 mg powder for solution for injection.

Pack sizes of 1 vial and 5 (5x1) vials with powder for solution for injection.

Hospital packs: 1 vial, 5 (5x1) vials, 10 (10x1) vials and 20 (20x1) vials with powder for solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder

Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom

Marketing authorization dates and numbers

PL 16189/0036

Date of first authorisation: 20/03/1998
Date of last renewal: 31/07/2007

Drugs

Drug Countries
PROTIUM Ireland, United Kingdom

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