PROSULF Solution for injection Ref.[9525] Active ingredients: Protamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K

Product name and form

Prosulf 10mg/ml Solution for Injection.

Protamine Sulfate 10mg/ml Solution for Injection.

Pharmaceutical Form

Solution for injection.

A clear, colourless solution.

Qualitative and quantitative composition

Protamine Sulfate 10mg/ml.

Active Ingredient Description
Protamine

Protamine is a potent antidote for heparin. Its precise mechanism of action is unknown. However, when the strongly basic protamine combines with the strongly acid heparin, a stable salt is formed lacking in anticoagulant activity.

List of Excipients

Sodium chloride
Hydrochloric acid 3M
Sodium hydroxide 3M
Water for injections

Pack sizes and marketing

5ml and 10ml neutral type 1 hydrolytic glass ampoules in pack sizes of 10 ampoules in cartons.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K

Marketing authorization dates and numbers

PL 29831/0180

Date of first authorisation: 17 May 1991
Date of latest renewal: 09 February 2009

Drugs

Drug Countries
PROSULF Israel, Singapore, United Kingdom

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