FUROSEMIDE Solution for injection Ref.[6868] Active ingredients: Furosemide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Product name and form

Furosemide 20mg/2ml Solution for Injection.

Furosemide 50mg/5ml Solution for Injection.

Furosemide 250mg/25ml Solution for Injection.

Pharmaceutical Form

Colourless or almost colourless sterile solution intended for parenteral administration to human beings.

Qualitative and quantitative composition

Each 1ml of solution contains 10mg of Furosemide B.P.

Excipient(s) with known effect: Sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Furosemide

Furosemide inhibits active chloride transport in the thick ascending limb. Re-absorption of sodium, chloride from the nephron is reduced and a hypotonic or isotonic urine produced. The evidence from many experimental studies suggests that furosemide acts along the entire nephron with the exception of the distal exchange site.

List of Excipients

Sodium Chloride B.P.
Sodium Hydroxide B.P.
Water for Injections B.P.

Pack sizes and marketing

2ml, 5ml & 25ml One point cut (OPC) amber glass ampoules, glass type 1 Ph.Eur. packed in cardboard cartons to contain 10 × 2ml or 10 × 5ml or 10 × 25ml ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Marketing authorization dates and numbers

PL 2848/0103

24/09/1990 / 18/06/2003

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