PRENOXAD Solution for injection/infusion Ref.[27751] Active ingredients: Naloxone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom

Product name and form

Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe.

Pharmaceutical Form

Solution for injection/infusion in a pre-filled syringe.

Sterile, clear and colourless liquid with a pH of 3.0-4.0 and osmolarity 270 to 300 mOsmol/L.

Qualitative and quantitative composition

The active substance is Naloxone Hydrochloride 1 mg/ml.

1 ml of solution – contains 1 mg of naloxone hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Naloxone

Naloxone hydrochloride, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors. It reveals very high affinity for the opioid receptor sites and therefore displaces both opioid agonists and partial antagonists, such as pentazocine, for example, but also nalorphine.

List of Excipients

Sodium chloride
Dilute hydrochloric acid (for pH adjustment)
Water for injections
Nitrogen

Pack sizes and marketing

Sterile solution for injection presented in a Glass (Type I) 2ml prefilled syringe. The pack contains two 23G x 1¼" needles.

Marketing authorization holder

Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom

Marketing authorization dates and numbers

PL 12064/0125

Date of first authorisation : 29/06/2012

Drugs

Drug Countries
PRENOXAD Australia, Estonia, France, Ireland, United Kingdom

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