NALOXONE B. BRAUN 0.4 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION
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How to use NALOXONE B. BRAUN 0.4 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION
Introduction
Package Leaflet: Information for the Patient
Naloxona B. Braun 0.4 mg/ml Solution for Injection and Infusion
Naloxone Hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack:
- What Naloxona B. Braun is and what it is used for
- What you need to know before you use Naloxona B. Braun
- How to use Naloxona B. Braun
- Possible side effects
- Storage of Naloxona B. Braun
- Contents of the pack and other information
1. What Naloxona B. Braun is and what it is used for
Naloxona B. Braun is a medicine used to counteract the effects of opioid overdose, for example, morphine overdose.
Naloxona B. Braun is used to reverse the unwanted effects of opioids to counteract central nervous system and respiratory depression (breathing difficulties) that can be life-threatening.
Naloxona B. Braun is also used to diagnose acute opioid overdose or poisoning. If a woman has received pain relief medication during childbirth, the newborn can be treated with Naloxona B. Braun to reverse the unwanted effects of opioids, for example, if they have breathing problems or central nervous system depression.
2. What you need to know before you use Naloxona B. Braun
Do not use Naloxona B. Braun
- If you are allergic (hypersensitive)to naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking Naloxona B. Braun.
Special care should be taken
- If you have physical dependence on opioids (e.g., morphine), or if you have received high doses of these drugs (you may experience intense withdrawal symptoms after receiving Naloxona B. Braun due to rapid reversal of the opioid effect; these symptoms can include high blood pressure, palpitations, severe breathing difficulties, or cardiac arrest).
- If you have any heart or circulatory problems(as it is more likely that side effects such as high or low blood pressure, palpitations, or severe breathing difficulties will occur).
Using Naloxona B. Braun with other medicines
Tell your doctor or pharmacist if you are using or have recently used other medicines.
- If you are taking analgesic medicationsuch as buprenorphine.The analgesic effect may be even more intense while you are being treated with Naloxona B. Braun. However, the reversal of unwanted effects, such as respiratory depression caused by buprenorphine, is limited.
- If you are taking sedativesas Naloxona B. Braun may have a less rapid effect.
- If you are taking any medication that may affect your heart or circulation(e.g., medications for hypertension such as clonidine), including those not prescribed.
Using Naloxona B. Braun with alcohol
Tell your doctor if you have drunk alcohol. In patients with multiple intoxication (with opioids and sedatives or alcohol), Naloxona B. Braun may have a less rapid effect.
Pregnancy and breastfeeding
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 using this medicine.
Pregnancy
There is limited information on the use of Naloxona B. Braun in pregnant women. During pregnancy, your doctor will weigh the benefits of Naloxona B. Braun against the possible risks to the unborn baby. Naloxona B. Braun may cause withdrawal syndrome in the newborn.
Breastfeeding
It is unknown whether Naloxona B. Braun passes into breast milk and whether it affects breastfed infants. Therefore, breastfeeding is not recommended for 24 hours after treatment.
Driving and using machines
After receiving Naloxona B. Braun to reverse the effects of opioids, you should not drive, operate machinery, or perform any other activity that requires physical or mental effort for at least 24 hours, as the effects of the opioids may recur.
Patients on low-sodium diets should note that this medicine contains 88.5 mg (3.8 mmol) of sodiumper maximum daily dose.
3. How to use Naloxona B. Braun
The recommended doses that will be administered to you are:
To reverse the unwanted effects of opioids:
Adults: 0.1 to 0.2 mg, if necessary, additional injections of 0.1 mg may be administered.
Children: 0.01 to 0.02 mg per kg of body weight, if necessary, additional injections of the same dose may be administered.
Diagnosis and treatment of opioid overdose or poisoning:
Adults: 0.4 mg to 2 mg, if necessary, injections may be repeated at 2- to 3-minute intervals. The maximum dose should not exceed 10 mg.
Children: 0.01 mg per kg of body weight, if an additional dose is necessary, the dose may be increased in the next injection to 0.1 mg per kg.
Reversal of unwanted effects of opioids in newborns whose mothers have received opioids:
0.01 mg per kg of body weight; if necessary, additional injections may be administered.
To reverse the unwanted effects of opioids (in adults, children, and also in newborns), patients are monitored to ensure that the desired effect of Naloxona B. Braun is achieved. If necessary, additional doses may be administered every 2 hours.
In elderly patients with heart or circulatory problems or in those receiving medications that may cause circulatory or heart disorders (e.g., cocaine, methamphetamine, tricyclic antidepressants, calcium channel blockers, beta-blockers, digoxin), Naloxona B. Braun will be used with caution as serious side effects such as rapid heartbeat (ventricular tachycardia) and fibrillation have occurred.
If you feel that the effect of Naloxona B. Braun is too strong or too weak, tell your doctor.
Method of administration
Naloxona B. Braun will always be administered by intravenous or intramuscular injection (into a vein or muscle) or, after dilution, as an intravenous infusion (over a long period). Naloxona B. Braun will be administered by your anesthesiologist or a doctor with experience.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
It may be difficult to know which side effects are caused by Naloxona B. Braun, as it is always administered after other medicines have been used.
The following side effects may be serious. If you experience any of the following side effects, consult a doctor immediately.
Common (may affect up to 1 in 10 people):
- Rapid heartbeat
Uncommon (may affect up to 1 in 100 people):
- Changes in the way your heart beats, slow heart rate
Rare (may affect up to 1 in 1,000 people):
- Seizures
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions (hives, nasal congestion or cold, difficulty breathing, Quincke's edema (large swelling)), anaphylactic shock
- Fibrillation, cardiac arrest
- Fluid in the lungs (pulmonary edema)
Other side effects include:
Very common (may affect more than 1 in 10 people):
- Nausea
Common (may affect up to 1 in 10 people):
- Dizziness, headache
- Increased or decreased blood pressure (you may have a headache or feel dizzy)
- Vomiting
- If a very high dose is administered after an operation, you may feel agitated and experience pain (because the analgesic effects of the medications you received will have been counteracted, as well as the effects on your breathing)
Uncommon (may affect up to 1 in 100 people):
- Involuntary tremors, sweating
- Diarrhea, dry mouth
- Overbreathing (hyperventilation)
- Irritation of blood vessel walls (after IV administration); local irritation and inflammation (after IM administration)
Rare (may affect up to 1 in 1,000 people):
- Tension
Very rare (may affect up to 1 in 10,000 people):
- Discoloration and skin lesions (erythema multiforme)
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Naloxona B. Braun
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 label of the ampoule and the carton. The expiry date is the last day of the month stated.
Store the ampoules in the outer packaging to protect them from light.
Store below 25°C.
Store the diluted solutions below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
Composition of Naloxona B. Braun
The active substance is naloxone hydrochloride.
Each ampoule with 1 ml contains 0.4 mg of naloxone hydrochloride (as naloxone hydrochloride dihydrate).
The other ingredients are sodium chloride, diluted hydrochloric acid (for pH adjustment), and water for injections.
Appearance and packaging of the product
Naloxona B. Braunis a clear and colorless solution, in colorless glass ampoules containing 1 ml of solution for injection or infusion.
Package sizes: 5 and 10 ampoules
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder:
- Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Phone: +49/5661/71-0
Fax: +49/5661/71-4567
Manufacturer:
Hameln Pharmaceuticals GmbH
Langes Feld 13
31789 Hameln
Germany
or
B BRAUN MEDICAL S.A.Ronda de los Olivares, Parcela 11, Polígono Industrial Los Olivares23009 Jaén (Jaén)
Spain
You can obtain further information on this medicine from the local representative of the marketing authorization holder:
- BRAUN MEDICAL, S.A.
Ctra. de Terrassa, 121.
08191 Rubi (Barcelona)
Spain
This medicine is authorized in the Member States of the European Economic Area under the following names:
Austria | Naloxon B. Braun 0.4 mg/ml Injektionslösung |
Belgium | Naloxon B. Braun 0.4 mg/ml oplossing voor injectie |
Denmark | Naloxon B. Braun |
Finland | Naloxon B. Braun 0.4 mg/ml injektioneste, liuos |
Germany | Naloxon B. Braun 0.4 mg/ml Injektionslösung |
Greece | Naloxon B. Braun 0.4 mg/ml εν?σιμο δι?λυμα |
Ireland | Naloxone 400 micrograms/ml solution for injection |
Italy | Naloxone B. Braun 0.4 mg/ml soluzione iniettabile |
Luxembourg | Naloxon B. Braun 0.4 mg/ml Injektionslösung |
Norway | Naloxon B. Braun 0.4 mg/ml injeksjonsvæske, oppløsning |
Portugal | Naloxona B. Braun 0.4 mg/ml solução injectável |
Spain | Naloxona B. Braun 0.4 mg/ml solución inyectable |
Sweden | Naloxon B. Braun 0.4 mg/ml injektionsvätska, lösning |
Netherlands | Naloxon HCl B. Braun 0.4 mg/ml, oplossing voor injectie |
United Kingdom | Naloxone 400 micrograms/ml solution for injection |
Date of last revision of this leaflet:March 2018.
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products. http//www.aemps.gob.es/
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This information is intended only for healthcare professionals:
Expiry after first opening of the container
After the first opening of the container, the medicine should be used immediately.
Expiry after dilution
The physical-chemical stability of the diluted product has been demonstrated for 24 hours below 25°C.
From a microbiological point of view, the dilutions should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not exceed 24 hours at 2 to 8°C, unless the dilution has been made in controlled and validated aseptic conditions.
For IV infusion, Naloxona B. Braun is diluted only with sodium chloride 0.9% or glucose 5%. 5 ampoules of Naloxona B. Braun (2 mg) in 500 ml are equivalent to 4 μg/ml.
It is recommended not to mix Naloxona B. Braun infusions with preparations containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or solutions with alkaline pH.
This medicine is for single use only.
Please inspect the medicine visually before use (also after dilution). Use only clear and colorless solutions, practically free of particles.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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