0.4 mg / ml solution for injection / infusion
naloxone hydrochloride
What Nexodal is and what it is used for
Nexodal 0.4 mg/ml is a medicine used to counteract the effects of opioid overdose, e.g. overdose with morphine.
Nexodal 0.4 mg/ml is used to eliminate the side effects of opioids, to counteract life-threatening paralysis of the central nervous system and respiratory tract (difficulty breathing).
Nexodal 0.4 mg/ml is also used to diagnose acute opioid overdose or poisoning.
Naloxone hydrochloride contained in Nexodal may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Nexodal
Do not use Nexodal
- if you are allergic to naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Take special care with Nexodal
- if you are physically addicted to morphine or similar drugs, or if you have been given high doses of these drugs. You may experience withdrawal symptoms such as high blood pressure , palpitations, severe difficulty breathing or cardiac arrest.
- if Nexodal must be given to your newborn baby, as acute withdrawal symptoms may occur.
- if you have heart or circulation problems (as side effects such as high or low blood pressure , palpitations or severe breathing difficulties are likely to occur more quickly)
- if you are taking the painkiller buprenorphine, as naloxone has only a limited effect (see also section “Other medicines and Nexodal”).
Consult a doctor even if any of the above has previously applied to you.
Other medicines and Nexodal
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Please note that this may also apply to medicines that you have used before or that you may use in the future.
- If you are taking painkillers, such as buprenorphine. The analgesic effect can be stronger if you are treated with Nexodal.
- Severe hypertension has been reported when Nexodal has been used in coma due to clonidine overdose . Clone idin is a medicine used to treat withdrawal symptoms that occur when treatment with opioids has ended. It can also be used for high blood pressure , migraines and hot flashes in menopause.
Nexodal with food and drink
Tell your doctor if you have been drinking alcohol. In patients with mixed poisoning (with opioids and sedatives or alcohol), the effect of Nexodal may be slower.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
There are no adequate data from the use of Nexodal in pregnant women. During pregnancy, your doctor will consider the benefits of Nexodal against the possible risks to the fetus.
Nexodal may cause withdrawal symptoms in the infant (see section “Take special care with Nexodal”).
It is not known whether Nexodal 0.4 mg/ml passes into breast milk and it has not been established whether breastfed infants are affected by Nexodal 0.4 mg/ml. Breast-feeding should therefore be avoided for 24 hours after treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
After receiving Nexodal 0.4 mg/ml to eliminate the effects of opioids, do not drive, use machines or perform other physically or mentally demanding activities for at least 24 hours, as the effects of the opioids may recur…
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Nexodal contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free’.
How to use Nexodal
Dose
Your doctor will adjust the dose individually for you.
Adults
- Intravenous injection: 0.1 to 0.2 mg naloxone hydrochloride. If needed, additional 0.1 mg intravenous injections may be administered at 2-3 minute intervals. An additional injection may be needed within 1 to 2 hours.
Children and young people
- Initially an intravenous injection of 0.01-0.02 mg naloxone hydrochloride per kg body weight at 2-3 minute intervals. Additional doses may be needed at 1 to 2 hour intervals. Doses may differ depending on local recommendations.
Older
In elderly patients with pre-existing heart disease or in patients receiving medicinal products that may be cardiotoxic (toxic to the heart), naloxone hydrochloride should be used with caution.
Diagnosis of suspected acute opioid overdose or poisoning
Adults
- The starting dose is 0.4-2 mg naloxone hydrochloride intravenously . If necessary, a dose can be repeated at 2-3 minute intervals.
Children and young people
- The starting dose is 0.01 mg / kg body weight intravenously . If a satisfactory response is not obtained, a further increased dose of 0.1 mg / kg may be administered
- Dose one for children and adolescents may differ due to local recommendations.
Newborns whose mothers have received opioids:
The usual dose is 0.01 mg/kg body weight intravenously. If necessary, a dose can be repeated at 2-3 minute intervals. Dose one to newborns may differ due to local recommendations.
Method of administration
Nexodal can be given as an injection and injected into a vein (= intravenous) or into a muscle (= intramuscularly ) or can be given as an intravenous infusion by a doctor or nurse. The intramuscular administration of naloxone hydrochloride should only be used if intravenous administration is not possible.
Nexodal can be given as an intravenous infusion (drip) after dilution with
0.9% sodium chloride solution or 5% glucose solution.
Duration of treatment
The doctor will decide how long the treatment should last.
If you have the impression that the effect of Nexodal is too strong or too weak, talk to your doctor or pharmacist.
If you use more Nexodal than you should
If you receive more Nexodal than you should, contact a doctor or nurse immediately. He/she will take action if necessary.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Very common (affects more than 1 user in 10): nausea, malaise
Common (affects 1 to 10 users in 100): dizziness, headache, palpitations, low blood pressure, high blood pressure, vomiting, postoperative pain
Uncommon (affects 1 to 10 users in 1,000): tremors, sweating, changes in heart rate, slow heartbeat, diarrhea, dry mouth, rapid and deep breathing (hyperventilation), irritation of the vessel wall (after intravenous administration )
Rare (affects 1 to 10 users in 10,000): seizures, nervous tension
Very rare (affects less than 1 user in 10,000): rapid and irregular heartbeat, cardiac arrest, fluid accumulation in the lungs, allergic reactions ( hives, runny nose, difficulty breathing, Quincke’s edema ), allergic shock, erythema multiforme
When Nexodal is given to people who are addicted to morphine or similar drugs, acute withdrawal symptoms may occur (eg high blood pressure and heart symptoms). This can also occur in infants whose mothers are addicted to opioids.
If an overdose of Nexodal is given after surgery, you may become agitated and feel pain (because the effects of the painkiller you have been given have been counteracted, as well as the effects on your breathing).
How to store Nexodal
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and ampoule after “EXP”. respectively “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store the ampoules in the outer carton. Sensitive to light.
The drug should be used immediately after opening.
After dilution, the product should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ° C, unless dilution has taken place under controlled and validated aseptic conditions.
This medicine is for single use only. Discard unused solutions.
Do not use Nexodal if the solution is discolored, cloudy, or contains particles.
For intravenous infusion , Nexodal 0.4 mg / ml should be diluted with sodium chloride 0.9% w / v or glucose 5% w / v.
5 ampoules of Nexodal 0.4 mg / ml (2 mg) diluted to 500 ml give a final concentration of 4 micrograms / ml.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is naloxone hydrochloride.
Each ampoule of 1 ml solution for injection/infusion contains 0.4 mg of naloxone hydrochloride (as naloxone hydrochloride dihydrate).
The other ingredients are sodium chloride, hydrochloric acid (diluted), and water for injections.
What the medicine looks like and contents of the pack
Nexodal is a clear and colorless solution for injection/infusion.
Nexodal is available in packs of 10 ampoules of 1 ml solution for injection/infusion.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85 / 1B
A-3002 Purkersdorf, Austria
Manufacturer
Hikma Italia SPA
Viale Certosa
10 Pavia (PV) 27100, Italy
GL Pharma GmbH
A-1160 Vienna, Austria
AOP Orphan Pharmaceuticals GmbH
A-1190 Vienna, Austria
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Nexodal 0.4 mg / ml solution for injection or infusion
Estonia: Nexodal 0.4 mg / ml süste- / infusioonilahus
Finland: Nexodal 0.4 mg / ml injection / infusion test, liuos
Ireland: Naloxone 400 micrograms / ml solution for injection or infusion
Italy: Nexodal 0.4 mg / ml inoperable or infusion solution
Netherlands: Naloxone Orpha 0.4 mg / ml solution for injection or infusion
Romania: Nexodal 0.4 mg / ml injectable solution for perfusion
Slovenia: Nexodal 0.4 mg / ml injected with infusion or infusion
United Kingdom: Naloxone 400 micrograms / ml solution for injection or infusion
Hungary: Nexodal 0.4 mg / ml injectable vaginal infusion