Страна: Мальта
Язык: английский
Источник: Medicines Authority
NALOXONE HYDROCHLORIDE
Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland
V03AB15
NALOXONE HYDROCHLORIDE 400 µg/ml
SOLUTION FOR INJECTION
NALOXONE HYDROCHLORIDE 400 µg/ml
POM
ALL OTHER THERAPEUTIC PRODUCTS
Withdrawn
2006-11-28
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 Прочитать полный документ
Page 1 of 7 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 Прочитать полный документ