Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom
Naloxone 400 micrograms/ml solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear and colourless solution. pH: 3.1–4.5 Osmolality: 270-310 mOsMol/kg |
Each ampoule of 1 ml contains 0.4 mg naloxone hydrochloride (as naloxone hydrochloride dihydrate).
Excipient: 1 ml solution for injection/infusion contains 3.54 mg of sodium.
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 |
|---|
|
Water for injections |
Type I clear, colourless glass ampoules.
Packs of 5 or 10 ampoules of 1 ml.
Not all pack sizes may be marketed.
hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom
PL 01502/0141
24/04/2012
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