Naloxone Accord

1. What is Naloxone Accord and what is it used for

Naloxone Accord is a medicine used to counteract the effects of opioid overdose, e.g., morphine overdose.
Naloxone Accord is used to reverse the unwanted effects of opioids, to counteract life-threatening central nervous system and respiratory depression (breathing difficulties).
Naloxone Accord is also used to diagnose acute opioid overdose or poisoning.
If a woman has been given painkillers during childbirth, the newborn can be treated with Naloxone Accord to reverse the unwanted effects of opioids, e.g., if they have breathing difficulties or central nervous system depression.
Naloxone Accord in a pre-filled syringe should not be used in infants with a body weight of less than 4 kg.

2. Important information before using Naloxone Accord

When not to use Naloxone Accord:

allergic (hypersensitive)to naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Naloxone Accord in a pre-filled syringe should not be used in infants with a body weight of less than 4 kg.

Warnings and precautions

Before starting treatment with Naloxone Accord, the patient should discuss it with their doctor or pharmacist.
Special caution will be exercised:
In cases of physical dependence on opioids(e.g., morphine) or in cases of receiving high doses of these drugs, as Naloxone Accord may cause severe withdrawal symptoms due to the rapid reversal of opioid effects, such as high blood pressure, rapid heartbeat, severe breathing difficulties, or cardiac arrest.
In cases of cardiovascular disorders, due to the increased risk of side effects, such as high or low blood pressure, rapid heartbeat, or severe breathing difficulties.

Naloxone Accord and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken:
In cases of using painkillers, such as buprenorphine, their pain-relieving effect may be enhanced during treatment with Naloxone Accord, and the reversal of unwanted effects, such as respiratory depression caused by buprenorphine, is limited.
In cases of using sedatives, as Naloxone Accord may act more slowly.
In cases of using any medicines that may affect the heart or circulation(e.g., antihypertensive drugs such as clonidine), even those available without a prescription.

Naloxone Accord and alcohol

The patient should inform their doctor if they have consumed alcohol. Naloxone Accord may act more slowly in patients with multiple intoxications (opioids and sedatives or alcohol).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
There is limited data on the use of Naloxone Accord in pregnant women.
Naloxone Accord may only be used during pregnancy if the doctor considers the benefits of using the medicine to outweigh the risks to the unborn child. Naloxone Accord may cause withdrawal symptoms in the newborn.
Breastfeeding
It is not known whether Naloxone Accord passes into breast milk or has an effect on breastfed infants. Therefore, breastfeeding should be discontinued for 24 hours after treatment.

Driving and using machines

After receiving Naloxone Accord to reverse opioid effects, the patient should not drive vehicles, operate machinery, or perform any activities that require physical or mental effort for at least 24 hours, as there is a risk that the opioid effects may recur.

Naloxone Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL of solution, which means it is considered "sodium-free".

3. How to use Naloxone Accord

Recommended dose for the patient:
Reversal of unwanted opioid effects:
Adults: 0.1 – 0.2 mg, if necessary, additional injections of 0.1 mg may be given.
Children: 0.01 – 0.02 mg/kg body weight, if necessary, additional injections may be given in the same dose.
Diagnosis and treatment of opioid overdose or poisoning:
Adults: 0.4 – 2 mg, if necessary, injections may be repeated at 2-3 minute intervals. The maximum dose should not exceed 10 mg.
Children: 0.01 mg/kg body weight, if an additional dose is necessary, the dose may be increased to 0.1 mg/kg in the next injection.
Reversal of unwanted opioid effects in newborns whose mothers have received opioids:
0.01 mg/kg body weight, if necessary, additional injections may be given.
To reverse unwanted opioid effects (in adults, children, and newborns), patients are monitored to ensure the desired effect of Naloxone Accord. If necessary, additional doses may be given every 1-2 hours.
In elderly patients with heart or circulation problems or those taking medicines that may cause heart or circulation disorders (e.g., cocaine, methamphetamine, tricyclic antidepressants, calcium channel blockers, beta-blockers, digoxin), Naloxone Accord should be used with caution, as severe side effects, such as rapid heartbeat (ventricular tachycardia) and ventricular fibrillation, have occurred.
Naloxone Accord in a pre-filled syringe should not be used in infants with a body weight of less than 4 kg.
If the patient feels that the effect of Naloxone Accord is too strong or too weak, they should consult their doctor.
Method of administration
Naloxone Accord is always given by intravenous or intramuscular injection (into a vein or muscle) or, after dilution, by intravenous infusion (over a longer period). Naloxone Accord is administered by an anesthesiologist or an experienced doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Naloxone Accord can cause side effects, although not everybody gets them.
It may be difficult to determine which side effects are caused by Naloxone Accord, as it is always given after the use of other medicines.

The following side effects may be serious. If the patient experiences any of the following side effects, they should immediately consult their doctor:

Common side effects (may occur in less than 1 in 10 patients):

• Rapid heartbeat.

Uncommon side effects (may occur in less than 1 in 100 patients):

• Abnormal heart rhythm, slow heartbeat.

Rare side effects (may occur in less than 1 in 1,000 patients):

• Seizures.

Very rare side effects (may occur in less than 1 in 10,000 patients):

• Allergic reactions (hives, runny nose or cold, breathing difficulties, angioedema (massive swelling)), anaphylactic shock.
• Ventricular fibrillation, cardiac arrest.
• Fluid in the lungs (pulmonary edema).

Other side effects include:

Very common side effects (may occur in less than 1 in 10 patients):

• Nausea.

Common side effects (may occur in less than 1 in 10 patients):

• Dizziness, headache.
• High or low blood pressure (may cause headache or feeling of fainting).
• Vomiting.
• In cases of post-operative administration, the patient may become excited and experience pain (as the pain-relieving effect of the administered medicines is neutralized, as well as their effect on breathing).

Uncommon side effects (may occur in less than 1 in 100 patients):

• Involuntary trembling or shaking, sweating.
• Diarrhea, dry mouth.
• Excessive breathing (hyperventilation).
• Irritation of the vessel wall has been reported after intravenous administration; local irritation and inflammation have been reported after intramuscular administration.

Rare side effects (may occur in less than 1 in 1,000 patients):

• Tension.

Very rare side effects (may occur in less than 1 in 10,000 patients):

• Discoloration and skin changes (erythema multiforme)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Naloxone Accord

The medicine should be stored out of sight and reach of children.
Naloxone Accord should not be administered after the expiry date stated on the carton (carton with a twist-off closure) and the syringe label after: EXP. The expiry date refers to the last day of the month.
There are no special storage temperature recommendations for the medicine.
The pre-filled syringe should be stored in the outer packaging to protect it from light.
Shelf life after first opening
The medicinal product should be used immediately after first opening.
Shelf life after dilution
Chemical and physical stability has been demonstrated for 36 hours at a temperature of 2 to 8°C and at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions prior to use – under normal conditions, the storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless the dilution of the medicine takes place in controlled and certified aseptic conditions.
Do not use this medicine if a change in the color of the solution or visible signs of deterioration are observed.
Do not dispose of any medicines via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Naloxone Accord contains

The active substance of the medicine is naloxone hydrochloride. Each pre-filled syringe with a capacity of 1 mL contains 400 micrograms of naloxone hydrochloride (as naloxone hydrochloride dihydrate).
The other ingredients are: sodium chloride, hydrochloric acid (for pH adjustment), water for injections.

What Naloxone Accord looks like and contents of the packaging

Naloxone Accord is a clear, colorless solution for injection/infusion in a pre-filled syringe, practically free from particles.
The pre-filled syringe with a capacity of 1 mL is made of colorless glass with a plunger stopper (gray rubber stopper) and a barrel (polypropylene). The syringe cylinder has a graduation every 0.1 mL.
The pre-filled syringe is provided with a needle (23 G; 30 mm), packaged in an outer carton (twist-off closure carton).
Pack sizes: one pre-filled syringe and one needle.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
95-200 Pabianice
or
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca
Barcelona, 08040
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: July 2024

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Information intended for healthcare professionals only:

Shelf life after first opening and after dilution: see section 5.
For intravenous infusion, Naloxone Accord should be diluted with sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) solution. With five pre-filled syringes of Naloxone Accord (2 mg) in 500 mL, a concentration of 4 micrograms/mL is obtained.
Naloxone Accord should not be administered in the same infusion as products containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or solutions with an alkaline pH.
This medicinal product is intended for single use only.
The medicinal product should be inspected visually before use (also after dilution). Only clear, colorless solutions that are practically free from particles should be used.