Naloxone Hydrochloride 400 Micrograms/Ml Solution For Injection
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NALOXONE HYDROCHLORIDE 400 MICROGRAMS/ML solution for injection
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of this medicinal product is NALOXONE HYDROCHLORIDE 400 MICROGRAMS/ML, solution for injection, but will be referred as Naloxone Injection throughout the whole leaflet.
In this leaflet:
1. What Naloxone Injection is and what it is used for
2. Before you are given Naloxone Injection
3. How Naloxone Injection is given
4. Possible side effects
5. Storing Naloxone Injection
6. Further information
1. WHAT NALOXONE INJECTION IS AND WHAT IT IS USED FOR
Naloxone belongs to a group of medicines known as opioid antagonists.
It is used to treat very shallow breathing that may be caused by opioid painkillers. It may also be used to diagnose opioid overdose.
2. BEFORE YOU ARE GIVEN NALOXONE INJECTION
Naloxone Injection must not be administered if you are hypersensitive (allergic) to Naloxone or any of the other ingredients of Naloxone Injection.
Please note:
You should let your doctor know if you are dependent on opioid painkillers such as diamorphine (heroin), even if you are being treated with methadone, as naloxone may cause withdrawal symptoms.
Take special care with Naloxone Injection and tell your doctor if you:
- have problems with your heart or circulation,
- are in pain,
- have recently been given a large dose of opioid painkillers,
- are physically dependent on opioids and that are pregnant, planning pregnancy or breast-feeding,
- are taking medicines that may affect your heart function,
- have just had an operation.
Taking other medicines
Naloxone may interfere with the actions of other medicines.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Inform your doctor if your are breast-feeding.
Driving and using machines:
You should not drive or operate machinery until you have fully recovered from the effects of Naloxone Injection Important information about some of the ingredients of Naloxone Injection:
Each ampoule contains 3.5 mg (0.154 mmol) of sodium.
3. HOW NALOXONE INJECTION IS GIVEN
Dosage:
Your doctor will decide the dose that is best for you. The dose administered will be dependent on what symptoms you present and where the injection is given.
The following information is intended for medical or healthcare professionals only:
Drug name:
NALOXONE HYDROCHLORIDE 400 MICROGRAMS/ML solution for injection
Safety Information:
Solution for injection.
Incompatibilities:
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Instructions on preparation and dilution:
Naloxone may be diluted for intravenous infusion in normal saline or 5% dextrose solutions. The addition of 2 mg of naloxone in 500 ml of either solution provides a concentration of 4 micrograms /ml. Infusion should be commenced as soon as practicable after preparation of the mixture in order to reduce microbiological hazards. The rate of administration should be titrated in accordance with the patient's response. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Any unused product or waste material should be disposed of in accordance with local requirements.
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Methods of Administration: A nurse or doctor will give you an injection. The injection may be given into the muscle, vein or skin.
If you receive more Naloxone Injection than you should: Please consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Naloxone Injection can cause side effects, although not everybody gets them.
The frequency of side effects is classified into the following categories: Very common In more than 1 in 10 patients
Common In more than 1 in 100 patients, but less than 1 in 10 patients
Uncommon In more than 1 in 1,000 patients, but less than 1 in 100 patients
Very rare In less than 1 in 10,000 patients, including isolated reports
It may be difficult to know what side effects Naloxone Injection has, because it is always given after other drugs have also been used.
Nervous system disorders: • Common: Headache.
_ • Rare: Seizures.
Fast heart beat.
Cardiac disorders:
Uncommon:
Rare: Changes in the way your heart beats.
• Rare: Increased or decreased blood pressure.
Very rare: Fluid on the lungs (pulmonary oedema). Common: Nausea, vomiting.
Vascular disorders Respiratory disorders:
Gastrointestinal disorders
General disorders and administration site conditions:
• Uncommon: Opioid withdrawal syndrome. The signs and symptoms of opioid withdrawal syndrome may include but are not limited to the following: chills, nausea, vomiting, diarrhea, anxiety, restlessness, irritability, sweating, shivering, tremor, tachycardia and increased blood pressure.
• Rare: You may become excited and feel pain (because the painkilling effects of the medicines you were given will have been counteracted as wel. the effects on your breathing), over breathing (hyperventilation).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE NALOXONE INJECTION
Keep out of the reach and sight of children.
Expiry date: Do not use after the expiry date stated on the ampoule. The expiry date refers to the last day of the month.
Storage conditions: Store in the original package.
Store the ampoule in the outer carton until used to protect from light.
Store diluted solutions below 20°C.
Medicines should not be disposed of via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Naloxone Injection contains:
The active substance is Naloxone hydrochloride.
Each 1 ml ampoule contains 440 micrograms Naloxone hydrochloride as dihydrate, equivalent to 400 micrograms Naloxone hydrochloride.
The other ingredients are sodium chloride, water for injection, sodium hydroxide or hydrochloric acid (for pH adjustment).
What Naloxone Injection looks like and contents of the pack:
Your medicinal product is a clear and colourless solution in clear glass ampoule containing 1 ml solution for injection. Boxes of 10 ampoules.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Marketing Authorisation Holder / Manufacturer
Laboratoire Aguettant 1, rue Alexander Fleming 69007 LYON - France
Distributor:
AGUETTANT LTD The Barn 41a Main Road Cleeve
SOMERSET BS49 4NZ England
This leaflet was last approved in February 2013.
Administration:
It depends how much is needed to reverse the effects on respiratory depression. The following is a guide.
For adults:
• 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.
For children:
reversed by to 3 minutes if
• 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.
• To treat opoid-induced depression in neonates resulting from the administration of opioid analgesics to the mother during labour may be administering naloxone hydrochloride 10 micrograms / kg body weight to the infant by IM, IV or SC injections, repeated at intervals of necessary. Alternatively, a single IM dose of about 60 micrograms / kg may be given at birth for a more prolonged action.
Patients are monitored to make sure the effect of the naloxone lasts as long as the drugs it is counteracting. In adult, additional doses may be given every 1-2 hours if necessary.
Storage and Shelf-life:
Store the ampoule in the outer carton until used to protect from light.
Shelf-life: 3 years.
Shelf-life after first opening: The medicinal product should be used immediately.
Shelf-life after dilution: Chemical and physical in-use stability has been demonstrated for 48 hours below 20°C.
From the microbiological point of view, the dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to 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 in controlled and validated aseptic conditions.