Naloxone Hydrochloride 400 micrograms/ml Solution for Injection/Infusion

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

NALOXONE HYDROCHLORIDE

Предлага се от:

Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

АТС код:

V03AB15

INN (Международно Name):

NALOXONE HYDROCHLORIDE 400 µg/ml

Лекарствена форма:

SOLUTION FOR INJECTION

Композиция:

NALOXONE HYDROCHLORIDE 400 µg/ml

Вид предписание :

POM

Терапевтична област:

ALL OTHER THERAPEUTIC PRODUCTS

Статус Оторизация:

Withdrawn

Дата Оторизация:

2006-11-28

Листовка

PATIENT INFORMATION LEAFLET 

NALOXONE HYDROCHLORIDE 
20MICROGRAMS/ML SOLUTION FOR INJECTION 
NALOXONE HYDROCHLORIDE 
400MICROGRAMS/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 any further questions, ask your doctor or pharmacist. 
If any of the side effects becomes serious, or if you notice
any side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

The name of your
medicine is Naloxone Hydrochloride 20micrograms/ml Solution for
Injection, 
Naloxone Hydrochloride 400 micrograms/ml Solution for Injection. It
will be referred to as 
Naloxone injection for ease hereafter. 

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 to you 
4. Possible side effects 
5. How to store 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. Opioid medicines are 
strong painkillers such as morphine and codeine. In high doses these
painkillers can result in side 
effects which cause difficulty in breathing and drowsiness. 

These effects can be reversed by an opioid antagonist (blocks
the effects of opioids). 
Naloxone Injection may be used: 
  to treat the breathing problems caused by these opioid
painkillers 
  to help determine whether a patient has taken or received an
overdose of opioid drugs. 
  to reverse the depressant effects on breathing and on other
parts of the brain and spinal 
cord in newborn infants (resulting from the use of opioid painkillers
in the mother during 
childbirth). 

2.  BEFORE YOU ARE GIVEN NALOXONE INJECTION 

YOU SHOULD NOT BE GIVEN THIS MEDICINE IF you know that you are
allergic to naloxone, or to any 
of the other ingredients (l

Данни за продукта

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. TRADE NAME OF THE MEDICINAL PRODUCT 
Naloxone Hydrochloride Injection 400 micrograms/ml Solution for Injection  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each 1ml of solution contains 400 micrograms (0.4mg) Naloxone Hydrochloride present as Naloxone 
Hydrochloride Dihydrate Ph. Eur. 

3. PHARMACEUTICAL FORM 
Clear, colourless, sterile solution. 

CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 
Naloxone  may  be  used  for  the  complete  or  partial  reversal  of  opioid  depression,  including  mild  to 
severe  respiratory  depression  induced  by  natural  and  synthetic  opioids,  the  agonists/antagonists 
nalbuphine and pentazocine, or dextropropoxyphene. It may also be used for the diagnosis of suspected 
acute opioid overdosage. Naloxone may be used to counteract respiratory and other CNS depression in 
the newborn resulting from the administration of analgesics to the mother during childbirth. 

4.2. POSOLOGY AND METHOD OF ADMINISTRATION 
Naloxone is for intravenous, intramuscular or subcutaneous injection. It may also be administered by 
intravenous infusion. 
Intravenous infusion: 
Addition of 2mg of naloxone to 500ml of normal saline (0.9%) or to 500ml of 5% dextrose in water or 
in  saline  will  provide  a concentration  of  4  micrograms/ml  (0.004mg/ml).  After  24  hours,  any  unused 
solution should be discarded. The rate of infusion should be titrated according to the patient's response 
to the infused naloxone and to any previously administered bolus doses. 

Naloxone  should  not  be  mixed  with  preparations  containing  bisulphite,  metabisulphite,  long-chain  or 
high molecular weight anions or any solution having an alkaline p