MORPHINE SULFATE Solution for injection Ref.[7718] Active ingredients: Morphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Macarthys Laboratories Ltd t/a Martindale Pharma, Bampton Road, Harold Hill, Romford RM3 8UG

Product name and form

Morphine Sulfate 30mg in 1ml Solution for Injection.

Pharmaceutical Form

Solution for Injection.

A clear, colourless or almost colourless, particle free solution.

Qualitative and quantitative composition

Each 1 ml of solution contains 30 mg of Morphine Sulfate.

Excipients with known effect: Also, contains 2.23 mg of sodium per ml and sodium metabisulphite (E223).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Morphine

Morphine is a narcotic analgesic obtained from opium. Morphine acts as an agonist at opiate receptors in the CNS particularly Mu and to a lesser extent Kappa receptors. Mu receptors are thought to mediate supraspinal analgesia, respiratory depression and euphoria, and Kappa receptors, spinal analgesia, miosis and sedation.

List of Excipients

Sodium chloride,
Sodium metabisulfite (E223)
Water for injection

The pH may be adjusted with Sodium Hydroxide or Sulfuric Acid Solution.

Pack sizes and marketing

Clear, colourless 1ml Ph.Eur type1 glass ampoules containing sufficient solution to permit the removal of 1ml. 10 ampoules are packed into a cardboard carton.

Marketing authorization holder

Macarthys Laboratories Ltd t/a Martindale Pharma, Bampton Road, Harold Hill, Romford RM3 8UG

Marketing authorization dates and numbers

PL 01883/6178R

Date of first authorisation: 19th January, 1982
Renewal of authorisation: 19th August 2002

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