0.4 mg / ml solution for injection / infusion
naloxone hydrochloride
What Naloxone Hameln 0.4 mg / ml is and what it is used for
Naloxone Hameln 0.4 mg/ml is a medicine that counteracts the effects of opioid overdose, e.g. overdose with morphine.
Naloxone Hameln 0.4 mg/ml is used to eliminate the unwanted effects of opioids to counteract life-threatening paralysis of the central nervous system and respiration (difficulty breathing).
Naloxone Hameln 0.4 mg/ml is also used to diagnose acute opioid overdose or poisoning.
If a woman has been given painkillers during childbirth, the newborn baby can be treated with Naloxone Hameln 0.4 mg/ml to eliminate the unwanted effects of opioids, e.g. if he/she suffers from breathing difficulties or depression of the central nervous system.
Naloxone hydrochloride contained in Naloxone Hameln 0.4 mg/ml may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or healthcare professional if you have any further questions, and always follow their instructions.
Before you receive Naloxone Hameln 0.4 mg / ml
Do not use Naloxone Hameln 0.4 mg / ml
- if you are allergic to naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Naloxone Hameln 0.4 mg/ml.
Take special care with Naloxone Hameln 0.4 mg/ml and tell your doctor
- if you are physically addicted to opioids ( eg morphine) or have used high doses of these drugs (you may experience severe withdrawal symptoms after receiving Naloxone Hameln 0.4 mg / ml due to too rapid withdrawal of opioid effects; symptoms may include high blood pressure , palpitations, severe difficulty breathing or cardiac arrest).
- if you have heart or circulatory problems (because then side effects such as high or low blood pressure , palpitations or severe breathing difficulties are more likely to occur).
Other medicines and Naloxone Hameln 0.4 mg / ml
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- if you are taking painkillers such as buprenorphine . The analgesic effect may even be stronger while you are being treated with Naloxone Hameln 0.4 mg / ml. However, the reversal of the adverse effects, such as respiratory depression caused by buprenorphine, is limited.
- if you use sedatives , because then the effect of Naloxone Hameln 0.4 mg / ml may occur more slowly.
- if you are taking medicines that may affect your heart or your blood circulation (eg blood pressure medicines such as clonidine ), including over-the-counter medicines.
Naloxone Hameln 0.4 mg / ml with food, drink and alcohol
Tell your doctor if you have been drinking alcohol. In patients with mixed poisoning ( opioid poisoning and sedatives or alcohol), the effect of Naloxone Hameln 0.4 mg/ml may be slower.
Pregnancy and breastfeeding
There are insufficient data available on the use of Naloxone Hameln 0.4 mg/ml in pregnant women. During pregnancy, your doctor will consider the benefits of Naloxone Hameln 0.4 mg/ml against the potential risks to the fetus.
It is not known whether Naloxone Hameln 0.4 mg/ml passes into breast milk and it has not been established whether breastfed infants can be affected by Naloxone Hameln 0.4 mg/ml. Breast-feeding should therefore be avoided for up to 24 hours after treatment.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
After receiving Naloxone Hameln 0.4 mg/ml to counteract 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 opioids may recur.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Naloxone Hameln 0.4 mg / ml contains sodium
This medicine contains 3.54 mg sodium (the main ingredient in table salt/table salt) per ml. This corresponds to 0.2% of the maximum recommended daily intake of sodium for adults.
How Naloxone Hameln 0.4 mg / ml is administered
The usual doses given to you are
Elimination of the undesirable effects of opioids:
Adults: 0.1 – 0.2 mg, if necessary further injections of 0.1 mg may be given.
Children: 0.01 – 0.02 mg per kg body weight, if necessary additional injections of the same dose can be given.
Diagnosis of opioid overdose or poisoning:
Adults: 0.4 – 2 mg, the injections can be repeated if necessary at 2-3 minute intervals. The maximum dose of 10 mg should not be exceeded.
Children: 0.01 mg per kg body weight, if necessary dose one is increased in the next injection to 0.1 mg per kg.
Elimination of the undesirable effects of opioids in newborns whose mothers received opioids is
0.01 mg per kg body weight, if necessary further injection may be given.
To eliminate the undesirable effects of opioids (in adults, children, and even newborns), patients are monitored to ensure that the desired effect of Naloxone Hamelin 0.4 mg/ml is achieved.
Additional dose er can be given at 1-2 hour intervals, if necessary.
Naloxone Hameln 0.4 mg/ml should be used with caution in elderly patients with cardiac or circulatory problems or patients who have used agents that may cause cardiovascular disorders (eg cocaine, methamphetamine, tricyclic antidepressants, calcium channel blockers, beta-blockers, digoxin ), as serious side effects, such as rapid heartbeat ( ventricular tachycardia ) and fibrillation have occurred.
If you have the impression that the effect of Naloxone Hameln 0.4 mg/ml is too strong or too weak, talk to your doctor.
Method of administration
Naloxone Hameln 0.4 mg/ml is always given as an intravenous or intramuscular injection (into a vein or a muscle) or, after dilution, as an intravenous infusion (over a long period). Naloxone Hameln 0.4 mg/ml will be given to you by your anesthetist or another experienced physician.
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.
It can be difficult to know what side effects Naloxone Hameln 0.4 mg/ml has because it is always given after other substances have also been used.
Very common (may affect more than 1 user in 10):
– Nausea
Common (may affect up to 1 in 10 people):
– Dizziness
– Headache
– Fast heart rate
Elevated or decreased blood pressure (you may have a headache or feel dizzy)
Vomiting
– If an overdose is given after an operation, you may experience a hypersensitive condition and feel pain (because the pain-relieving effects of the medicines you have been given have also been counteracted as well as the effects on your breathing).
Uncommon (may affect up to 1 in 100 people):
– Involuntary trembling or shaking
– Sweating
– Changes in heart rhythm
– Slow heart rate
– Diarrhea
– Dry mouth
– Hyperventilation
Irritation of the blood vessel wall has been reported after intravenous administration
– Local irritation and inflammation have been reported after intramuscular administration
Rare (may affect up to 1 in 1,000 people):
– Seizures
– Nerve tension
Very rare (may affect up to 1 in 10,000 people):
– Allergic reactions ( hives, runny nose or cold, difficulty breathing, Quincke’s edema (severe swelling))
– Allergic shock
– Heart fibrillation
Cardiac arrest
– Accumulation of fluid in the lungs ( pulmonary edema )
– Discoloration and damage to the skin (erythema multiforme)
How to store Naloxone Hameln 0.4 mg / ml
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 ampoule label and the carton after “EXP” or “EXP”. The expiration date is the last day of the specified month.
Store the ampoules in the outer carton. Sensitive to light.
Do not store above 25 ° C.
Dilute solutions at a maximum of 25 ºC.
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 1 ml ampoule contains 0.4 mg of naloxone hydrochloride (as naloxone hydrochloride dihydrate)
- The other ingredients are sodium chloride, dilute hydrochloric acid (for pH adjustment ) and water for injections.
What the medicine looks like and contents of the pack
Naloxone Hameln 0.4 mg/ml is a clear and colorless liquid in a colorless glass ampoule containing 1 ml solution for injection/infusion.
Pack sizes: 5 and 10 ampoules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Manufacturer:
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
This medicinal product is authorized under the European Economic Area under the names:
| Denmark | Naloxone Hameln 0.4 mg / ml solution for injection / infusion |
| Netherlands | Naloxone HCl -hameln 0.4 mg / ml, solution for injection / infusion |
| Norway | Naloxone Hameln 0.4 mg / ml solution for injection / infusion |
| UK | Naloxone 400 micrograms / ml solution for injection / infusion |
| Sweden | Naloxone Hameln 0.4 mg / ml solution for injection or infusion |
| Germany | Naloxone hameln 0.4 mg / ml solution for injection or infusion |