Patient leaflet - Naloxone Hydrochloride Minijet 400 micrograms/ml solution for injection
1. What Naloxone Hydrochloride Injection is and what it is used for
Naloxene belongs to a group of medicines called “opioid
antagonists.” It counteracts strong painkillers (opiates).
Naloxone is used to restore the body’s breathing if it has been affected by strong painkillers (usually opioids such as morphine, heroin, methadone etc.) which may have been given during an operation for example.
It is also used for the same reason after an overdose of opioids (such as methadone) has been taken, or when an overdose of opioids is suspected.
As Naloxone is only used in medical emergencies, the injection will be given by a doctor or nurse in a hospital.
2. What you need to know before you are given Naloxone Hydrochloride Injection
Do not use Naloxone Hydrochloride Injection:
if you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6)
If this applies to you talk to your doctor or nurse.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before you are given Naloxone Hydrochloride Injection.
Other medicines and Naloxone
Tell your doctor if you are taking, have recently taken or might take medicines that may affect your heart, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Naloxone Hydrochloride Injection will only be given to you if your doctor considers the benefit of treatment outweighs the risk to the developing or new born baby.
Driving and using machines
Not applicable, this medicine is intended for use only in emergencies.
3. How Naloxone Hydrochloride Injection will be given to you
Important: Naloxone will be given to you by a doctor or nurse. Your doctor will choose the dose that is right for you
Adults and the elderly
- To treat an overdose or suspected overdose of opioids, between 400 and 2000 micrograms may be given every 2-3 minutes.
- After an operation 100-200 micrograms may be given every 2-3 minutes.
Naloxone is always given by injection by a doctor or health professional, usually into a blood vessel. It may be given slowly through a drip. It can be given into a muscle or under the skin.
Children
- The usual dose is 10 micrograms for every kg they weigh increased to 100 micrograms per kg if there is not a good enough response.
Patients are monitored to make sure the effect of the Naloxone lasts as long as the drugs it is counteracting. Additional doses may be given every 1-2 hours if necessary.
If you think you have been given more Naloxone Hydrochloride Injection than you should
As this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too little or too much. However, if you think you have been given too much of this medicine, tell your doctor.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines Naloxone can cause side effects, although not everybody gets them.
Side effects include:
Very Common: (probably occurring in more than 1 in 10 people)
- Nausea
Common: (probably occurring in less than 1 in 10 people)
- Violent Behaviour
- Ventricular tachycardia
- Hypotension
- Hypertension
- Vomiting
- Postoperative pain
Uncommon: (probably occurring in less than 1 in 100 people)
- Tremulousness
- Sweating
- Hyperventilation
Rare: (probably occurring in less than 1 in 1000 people)
- Seizures
Very Rare: (probably occurring in less than 1 in 10000 people)
- Fibrillation
Pulmonary oedema
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Naloxone Hydrochloride Injection
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date on the carton and vial label. The expiry date refers to the last day of that month.
Store below 25°C. Do not refrigerate or freeze.
Keep the glass vial in the outer carton in order to protect from light.
For single use only. The product should be used immediately after opening. Discard any unused portion.
Your doctor or nurse will make sure your medicine is correctly stored and
disposed of.
6. Further Information
What Naloxone Hydrochloride Injection contains
The active substance is naloxone hydrochloride (as the dihydrate). It contains 0.4 mg naloxone
hydrochloride (as the dihydrate) in each ml as the active ingredient. It also contains sodium chloride, hydrochloric acid for (pH adjustment) and “water for injections”.
What Naloxone Hydrochloride Injection looks like and contents of the pack
Naloxone is a clear, colourless sterile solution.
Vials and Luer Jet injectors are packed in outer cartons, which hold:
- 1 x 1 ml solution in a 3 ml vial and a Luer Jet injector (single pack)
- 10 single packs each containing 1 ml solution in a 3 ml vial and a Luer Jet injector (multipack)
A vial and a Luer Jet injector, when assembled form the Minijet pre-filled syringe.
Marketing Authorisation Holder
International Medication Systems (UK) Limited, First Floor, Templeback, 10 Temple Back, Bristol, BS1 6FL, UK.
Manufacturer/Importer
Elara Pharmaservices Limited, Iron Farm, 7 Grimes Gate, Diseworth, DE74 2QD, UK
Distributed by
Consilient Health (UK) Ltd.,
No. 1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last updated December 2021.
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