NALOXONE Solution for injection/infusion (2023)
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Περιεχόμενα
Name of the medicinal product
Naloxone 400 micrograms/ml solution for injection/infusion.
Qualitative and quantitative composition
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, ...
Pharmaceutical form
Solution for injection/infusion. Clear and colourless solution. pH: 3.1–4.5 Osmolality: 270-310 mOsMol/kg
Therapeutic indications
Complete or partial reversal of CNS and especially respiratory depression, caused by natural or synthetic opioids. Diagnosis of suspected acute opioid overdose or intoxication. Complete or partial reversal ...
Posology and method of administration
Posology Complete or partial reversal of CNS and especially respiratory depression, caused by natural or synthetic opioids Adults Dosage is determined for each patient in order to obtain optimum respiratory ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Naloxone 400 micrograms/ml must be given with caution to patients who have received high doses of opioids or are physically dependent on opioids. Too rapid reversal of the opioid effect can cause an acute ...
Interaction with other medicinal products and other forms of interaction
The effect of naloxone hydrochloride is due to the interaction with opioids and opioid agonists. When administered to subjects dependent on opioids, in some subjects the administration of naloxone hydrochloride ...
Pregnancy and lactation
Pregnancy For Naloxone hydrochloride insufficient clinical data on exposed pregnancies are available. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk for humans is ...
Effects on ability to drive and use machines
Patients who have received naloxone hydrochloride to reverse the effects of opioids should be warned not to take part in road traffic, to operate machinery or to engage in other activities demanding physical ...
Undesirable effects
The following frequency terminology is used: Very common ≥1/10, Common ≥1/100, <1/10, Uncommon ≥1/1,000, <1/100, Rare ≥1/10,000, <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available ...
Overdose
In view of the indication and the broad therapeutic margin overdose is not to be expected. Single doses of 10 mg naloxone hydrochloride i.v. have been tolerated without any adverse effects or changes in ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antidotes <b>ATC code:</b> V03AB15 Naloxone hydrochloride, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively ...
Pharmacokinetic properties
Absorption Naloxone hydrochloride is rapidly absorbed from the gastrointestinal tract but it is subject to considerable first-pass metabolism and is rapidly inactivated following oral administration. Although ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of acute and repeated dose toxicity. Naloxone hydrochloride was weakly positive in the Ames mutagenicity and <em>in ...
List of excipients
Water for injections Sodium chloride Hydrochloric acid, diluted (for pH adjustment)
Incompatibilities
It is recommended that infusions of naloxone hydrochloride should not be mixed with preparations containing bisulphite, metabisulphite, long-chain or high-molecular-weight anions, or solutions with an ...
Shelf life
3 years. <u>Shelf-life after first opening:</u> After first opening the medicinal product should be used immediately. <u>Shelf-life after dilution:</u> Chemical and physical in-use stability has been demonstrated ...
Special precautions for storage
Keep the ampoules in the outer carton in order to protect from light. Store below 25°C. Store diluted solutions below 25°C.
Nature and contents of container
Type I clear, colourless glass ampoules. Packs of 5 or 10 ampoules of 1 ml. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
For i.v. infusion Naloxone 400 micrograms/ml is diluted with sodium chloride 0.9% or glucose 5%. 5 ampoules of Naloxone 400 micrograms/ml (2 mg) per 500 ml give 4 µg/ml. This medicinal product is for single ...
Marketing authorization holder
hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom
Marketing authorization number(s)
PL 01502/0141
Date of first authorization / renewal of the authorization
24/04/2012
Date of revision of the text
30/09/2023
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