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PANCURONIUM BROMIDE 2MG/ML INJECTION

Active substance(s): PANCURONIUM BROMIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Pancuronium Bromide 2 mg/ml 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 gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor.
In this leaflet:
1. What Pancuronium Bromide Injection is and what it is used for
2. Before you use Pancuronium Bromide Injection
3. How to use Pancuronium Bromide Injection
4. Possible side effects
5. How to store Pancuronium Bromide Injection
6. Further information

1. WHAT PANCURONIUM BROMIDE INJECTION IS AND WHAT IT IS USED FOR
Pancuronium bromide is one of a group of medicines called ‘non-depolarising’ muscle
relaxants.
Pancuronium Bromide Injection is used to relax muscles during surgery, including
caesarean section and in intensive care.

2. BEFORE YOU USE PANCURONIUM BROMIDE INJECTION
Do not use Pancuronium Bromide Injection
• if you have shown signs of hypersensitivity (severe allergy) to pancuronium or bromide
in the past
Tell your doctor if the above applies to you before this medicine is used.

Take special care with Pancuronium Bromide Injection





if you have kidney, liver, lung or heart disease
if you have high blood pressure
if you have cancer, particularly lung cancer
if you suffer from any of the following conditions: myasthenia gravis, myasthenic
syndrome (other neuromuscular diseases) or poliomyelitis
• if you have fluid retention (you may have swelling around the ankles)
• if you have jaundice
Tell your doctor if any of the above applies to you before this medicine is used.
Special care will also be taken in the elderly, newborn babies, patients who are
dehydrated or in general poor health and patients who have blood abnormalities, such
as altered calcium, magnesium, potassium and protein levels (the doctor may do blood
tests to check for such abnormalities).

Taking/using other medicines
Pancuronium bromide must not be administered along with a “depolarising” muscle
relaxant, e.g. suxamethonium.
Other medicines used/taken at the same time as pancuronium bromide may interact,
hence, special care may be needed, for example:
• other muscle relaxants of the ‘non-depolarising’ type (e.g. mivacurium)
• some anaesthetic agents (e.g. halothane, ether, enflurane, isoflurane, methoxyflurane,
cyclopropane, thiopentone, methohexitone, ketamine, fentanyl, gammahydroxybutyrate,
etomidate)
• anticancer medicines belonging to a group called ‘alkylating agents’ (including
medicines known as ‘nitrogen mustards’)
• some antibiotics (e.g. aminoglycosides, metronidazole) and antifungal medicines (e.g.
imidazoles)
• medicines affecting the heart or blood pressure (glyceryl trinitrate, propranolol,
adrenaline, noradrenaline, alpha blockers, beta blockers, quinidine)
• water tablets (diuretics)
• medicines used to control anxiety (diazepam)
• antidepressants (e.g. tricylclic antidepressants, monoamine oxidase inhibitors)
• strong pain-killers (e.g. narcotics)
• steroid medicines
• medicines used to treat a disease affecting the muscles called ‘myasthenia gravis’
(neostigmine, pyridostigmine, edrophonium)
• phenytoin (antiepilepsy medicine)
• heparin and protamine (medicines used to control the ease with which the blood will
clot)
• azathioprine (a medicine used to prevent transplant rejection)
• theophylline (a medicine used to treat some breathing disorders)
• medicines used to increase the level of some salts in the blood (potassium chloride,
sodium chloride, calcium chloride)
• vitamin B1 (thiamine) if taken in high doses
• magnesium sulphate (used in the treatment of constipation, pre-eclampsia, abnormal
heart rhythms)
Please tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.

Pancuronium Bromide 2 mg/ml Injection
The following information is intended for medical or healthcare professionals only
Further to the information included in section 3, practical information on the preparation/
handling of the medicinal product is provided here.

Incompatibilities
Do not mix other solutions in the same syringe as a change in pH can cause
precipitation.

Instructions for use and handling
For single use only
Any unused solution should be discarded.
It is not recommended to give this product by infusion.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your
doctor will only use this medicine if the expected benefits outweigh any potential risk
to your baby.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Do not drive or use machines for 24 hours after full recovery from the muscle relaxant
effects of pancuronium bromide.

Important information about one of the ingredients of Pancuronium Bromide
Injection
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e.
essentially ‘sodium free’.

3. HOW TO USE PANCURONIUM BROMIDE INJECTION
This medicine will be given to you as an injection into a vein.

Dose
The dose of medicine given to you will depend upon your age, your weight, expected
duration of surgery, drugs that have been given to you previously and how well your
kidneys and liver are working.
The dose range in adults is typically between 50 and 100 micrograms/kg bodyweight.

If you are given too much or too little Pancuronium Bromide Injection
This medicine will be given to you in a hospital, under the supervision of a doctor. It is
unlikely that you will be given too much or too little, however, tell your doctor or nurse
if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, pancuronium bromide can cause side effects, although not everybody
gets them.

During use of Pancuronium Bromide Injection your doctor will be observing you
for:
• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling
of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in
swallowing or breathing), and you may feel you are going to faint
If this serious side effect occurs, urgent medical attention will be needed.

After you have come round, if any of the following happen, tell your doctor as
soon as possible:







breathing difficulties
unusually rapid heart beat, palpitations or irregular heart beat
pain, itching, local skin reaction or irritation particularly around the injection site
problems with your vision
skin rash
excess production of saliva

Your doctor may monitor for changes in your blood pressure.
If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor.

5. HOW TO STORE PANCURONIUM BROMIDE INJECTION
Keep out of the reach and sight of children

Expiry
This medicine must not be used after the expiry date which is stated on the vial ampoule
and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers
to the last day of that month.

Storage
The ampoules should be kept in the outer carton, in order to protect from light, and
stored in a refrigerator. They should not be frozen.

6. FURTHER INFORMATION
What Pancuronium Bromide Injection contains
The active substance is pancuronium bromide. Each millilitre (ml) of solution contains
2 milligrams (mg) of pancuronium bromide.
The other ingredients are sodium chloride, sodium acetate, and Water for Injections.

What Pancuronium Bromide Injection looks like and contents of the pack
Pancuronium Bromide Injection is a clear, colourless solution for injection which comes
in glass containers called ampoules.
It may be supplied in packs containing:
• 5 x 4 mg/2 ml ampoules
• 10 x 4 mg/2 ml ampoules
• 50 x 4 mg/2 ml ampoules
Not all packs may be marketed.

Marketing authorisation holder and manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK
This leaflet was last approved in 10/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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