PRENOXAD INJECTION KITS: MAJOR ALERT!
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a major warning that patients, carers and healthcare professionals with kits of the opioid overdose medicine Prenoxad Injection MUST visually check for the presence of two needles inside their kit.
T
he alert was released when the manufacturer received reports from France of missing needles in kits of
Prenoxad Injection. The kits normally contain two needles, along with the pre-filled syringe containing the active ingredient (naloxone) and the patient information leaflet.
The absence of the needles could mean that some individuals may not be able to administer life-saving doses of this medicine in an emergency.
To date, there have been no reports in the United Kingdom of kits with missing needles, but the potential for a small number of kits to have fewer than two needles cannot be ruled out.
The MHRA has said that anyone in possession of Prenoxad Injection kits should visually check the contents of their kits by holding the front of the sealed kit against a light source to confirm that there are two needles inside the kit. If the kit does
46
scottishpharmacist.com
not have two needles, it should be returned and replaced.
If it is not possible to confirm the presence of two needle packets visually, holders of Prenoxad Injection can open their kits without touching the pre-filled syringe (the tube with liquid in) to confirm there are two needles inside each kit.
Once the check is completed, the kit must be carefully closed to ensure the contents stay secure.
‘Patient safety is always our priority,’ said Dr Alison Cave, MHRA Chief Safety Officer. ‘We have taken prompt action to ensure kits with missing needles will no longer be given to patients. There are no concerns about the medicine in these kits and other products containing naloxone have not been affected by this manufacturing error.
Prenoxad Injection is used during emergencies for the complete or partial reversal of respiratory depression caused by natural and synthetic opioids, including methadone, but it
may also be used for the diagnosis of suspected severe opioid overdose.
Opioid overdose General symptoms of opioid overdose include pinpoint pupils, loss of consciousness, respiratory depression (breathing slows or stops), an extremely pale face that may feel clammy to the touch, bluish purple tinge to lips or fingernails, no response to noise, inability to speak, vomiting and/or making gurgling noises.
Anyone experiencing - or observing someone experiencing symptoms of opioid overdose - should immediately seek medical assistance. If there is nasal naloxone or injectable naloxone (with a needle) available, it should be administered according to the instructions in the kit. If someone has symptoms of an opioid overdose and is not breathing, 999 should be called and an ambulance requested immediately.
ANYONE IN POSSESSION OF PRENOXAD INJECTION KITS SHOULD VISUALLY CHECK THE KIT CONTENTS
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48
