METARAMINOL Solution for injection Ref.[9304] Active ingredients: Metaraminol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Torbay and South Devon NHS Foundation Trust, Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon TQ4 7FG, UK Medical enquiries: tsdft.medinfotorbaypharmaceuticals@nhs.net

Product name and form

Metaraminol 0.5mg/mL Solution for Injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless sterile solution, free from particles.

Glass ampoule containing a clear colourless solution with pH of 3.2 to 4.5 and osmolarity of 290mOsm/litre.

Qualitative and quantitative composition

Each 1 mL of solution contains 0.5mg of metaraminol (as tartrate).

Each 5mL ampoule contains 2.5mg metaraminol.

Each 10mL ampoule contains 5mg metaraminol.

Excipients of known effect:

Sodium chloride

Sodium metabisulfite

Each 1 mL of solution contains 149.6 micromol (3.44 mg) sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Metaraminol

Metaraminol is a potent sympathomimetic amine that increases both systolic and diastolic blood pressure, is an adrenergic receptor alpha-1 agonist. Metaraminol is indicated for prevention and treatment of the acute hypotensive state occurring with spinal anesthesia. It is also indicated as adjunctive treatment of hypotension due to hemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to trauma or tumor. Metaraminol is also used in the treatment of priapism, in spite of this application was not approved, it appears to be effective.

List of Excipients

Sodium chloride
Sodium metabisulfite (E223)
Water for injections

Pack sizes and marketing

Glass ampoule containing 5mL or 10mL of solution for injection.

Pack size of 10 ampoules in an outer carton.

Marketing authorization holder

Torbay and South Devon NHS Foundation Trust, Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon TQ4 7FG, UK

Medical enquiries: tsdft.medinfotorbaypharmaceuticals@nhs.net

Marketing authorization dates and numbers

PL 13079/0012

30/04/2019

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