Vecuronium bromide 10 mg powder for solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your anaesthetist or other doctor.
• If you get any side effects, talk to your anaesthetist or doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Vecuronium bromide is and what it is used for
2. What you need to know before Vecuronium bromide is given to you
3. How Vecuronium bromide is given
4. Possible side effects
5. How to store Vecuronium bromide
6. Contents of the pack and other information

• if you are allergic to vecuronium, the bromide ion or any of the other ingredients of this medicine (listed in section 6).

Tell your anaesthetist if this applies to you.

Talk to your anaesthetist before you receive Vecuronium bromide.

• if you are allergic to muscle relaxants
• if you have reduced renal function or a renal disease
• if you have had heart disease or a disease affecting your blood circulation
• if you have accumulation of fluid beneath the skin (for example swelling of the ankles)
• if you have a liver or a gallbladder disease
• if you have had diseases affecting nerves and muscles (for example polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)

Tell your anaesthetist if any of these applies to you.

Some conditions may influence the effects of Vecuronium bromide, for example:

• low calcium levels in the blood (hypocalcaemia; caused by blood transfusion)
• low potassium levels in the blood (hypokalaemia; caused for example by severe vomiting or by severe diarrhoea)
• high magnesium levels in the blood (hypermagnesaemia)
• low levels of protein in the blood (hypoproteinaemia)
• too much acid in the blood or body tissue (acidosis)
• too much carbon dioxide in the blood (hypercapnia)
• loss of too much water from the body, for example by being sick, diarrhoea or sweating (dehydration)
• over-breathing (hyper ventilation) leading to too little carbon dioxide in the blood (alkalosis)
• general ill-health (cachexia)
• burns
• being very overweight (obesity)
• very low body temperature (hypothermia) during anaesthesia

If you have any of these conditions, your anaesthetist will take this into account when deciding the correct dose of Vecuronium bromide for you.

Tell your anaesthetist or doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines. Vecuronium bromide may affect other medicines or be affected by them.

Medicines which increase the effect of Vecuronium bromide:

• certain medicines used to make you sleep during surgery (anaesthetics; for example suxamethonium)
• certain medicines to treat bacterial infections (antibiotics; for example aminoglycosides, lincosamide and polypeptide antibiotics, acylamino-pencillin antibiotics)
• medicines which increase the amount of urine (diuretics or water tablets)
• certain medicines for heart disease or high blood pressure (calcium channel blockers, beta-blockers and quinidine)
• long-term concomitant use of certain anti-inflammatory medicines (corticosteroids)
• medicines used to treat mania, manic depressive illness (bipolar disorder) or depression (lithium)
• some laxatives such as magnesium salts
• the medicine called cimetidine, used to treat stomach ulcers, heartburn or acid reflux
• certain medicines for reducing pain (local anaesthetics; for example (lidocaine)
• short-term concomitant use of certain medicines used for epilepsy (phenytoin).

Medicines which decrease the effect of Vecuronium bromide:

• chronic use of medicines for epilepsy (phenytoin, carbamazepine)
• calcium chloride and potassium chloride.

Medicines with variable effect

• other muscle relaxants

Effect of Vecuronium on other drugs

• Vecuronium may make certain anaesthetics (for example lidocaine) work more quickly.

Your anaesthetist will take this into account when deciding the correct dose of Vecuronium for you.

Tell your anaesthetist if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Your anaesthetist may still give you Vecuronium bromide, but you need to discuss it first. Vecuronium bromide may be given to you if you are having a Caesarean section.

Do not drive or use machines until advised it is safe to do so. Because Vecuronium bromide is given as part of a general anaesthetic, you may feel tired, weak or dizzy for some time afterwards. Your anaesthetist will be able to advise you on how long the effects are likely to last.

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

Vecuronium bromide can be used in adults and children of all ages including infants and newborns. The dose will be determined by the anaesthetist.

The normal dose is 80 – 100 micrograms per kg body weight and the effect will last 24 - 60 minutes.

During the procedure it will be checked whether Vecuronium bromide is still working.

You may be given additional doses if they are needed. The dose that you receive will depend on various factors. These include

• the type of anaesthetic
• the expected length of the operation
• other drugs you are taking
• your state of health
• your age.

As your anaesthetist will be monitoring your condition carefully it is unlikely that you will be given too much Vecuronium bromide. However if this happens, your anaesthetist will keep you breathing artificially (on a ventilator) until you can breathe on your own. It is possible to counteract the effects of (too much) Vecuronium bromide and speed-up your recovery by giving you a drug that reverses the effect of Vecuronium bromide. You will be kept asleep while this takes place.

If you get any side effects, talk to your doctor or anaesthetist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is vecuronium bromide. Each vial contains 10 mg of vecuronium bromide.
• The other ingredients are citric acid anhydrous, disodium hydrogen orthophosphate anhydrous and mannitol (E421).

Vecuronium bromide is a white powder for solution for injection/infusion. There are 1 or 10 glass vials of vecuronium bromide in each pack.

Not all pack sizes may be marketed.

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