Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: DNE Pharma AS, Karihaugveien 22, 1086 Oslo, Norway
Ventizolve 1.26 mg nasal spray, solution in single-dose container.
| Pharmaceutical Form |
|---|
|
Nasal spray, solution (nasal spray). Clear, colourless solution. |
Each nasal spray container delivers 1.26 mg of naloxone (as hydrochloride dihydrate).
Excipient with known effect: One dose delivers 20 microgram benzalkonium chloride.
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 |
|---|
|
Povidone |
The immediate container consists of a type I glass vial with a chlorobutyl rubber stopper enclosed in a spray device comprised of polypropylene actuator and spray pin and a stainless steel cannula.
One pack contains 2 single-dose containers of 0.1 ml nasal spray, solution packed in a plastic cover.
DNE Pharma AS, Karihaugveien 22, 1086 Oslo, Norway
PA22993/001/001
Date of first authorisation: 22nd February 2019
| Drug | Countries | |
|---|---|---|
| VENTIZOLVE | Estonia, Finland, Ireland |
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