Package leaflet: Information for the patient

Vecuronium bromide 10mg, powder for solution for injection

Vecuronium bromide

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

-    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.

What is in this leaflet

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

1.    What Vecuronium bromide is and what it is used for

Vecuronium bromide is one of a group of drugs called muscle relaxants.

Muscle relaxants are used during an operation as part of a general anaesthetic. When you have an operation your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.

Normally, your nerves send messages called impulses to your muscles. Vecuronium bromide acts by blocking these impulses so that your muscles relax. Because your breathing muscles also relax, you will need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.

During the operation your anaesthetist will keep a check on the effect of the muscle relaxant, and if necessary will give you some more. At the end of surgery, the effects of the drug are allowed to wear off and you will start breathing on your own. Sometimes the anaesthetist will give you another drug to help speed this up.

2.    What you need to know before Vecuronium bromide is given to you

You should not be given Vecuronium bromide:

•    if you are allergic (hypersensitive) 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.

Warnings and precautions

Talk to your anaesthetist before you receive Vecuronium bromide:

•    if you are allergic to muscle relaxants

•    if you have had kidney, heart, liver or gall bladder disease

•    if you have had diseases affecting nerves and muscles

•    if you have fluid retention (oedema).

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

•    low potassium levels in the blood

•    high magnesium levels in the blood

•    low levels of protein in the blood

•    too much acid in the blood

•    too much carbon dioxide in the blood

•    loss of too much water from the body, for example by being sick, diarrhoea or sweating (dehydration)

•    over-breathing leading to too little carbon dioxide in the blood (alkalosis)

•    general ill-health

•    burns

•    being very overweight (obesity)

•    very low body temperature (hypothermia).

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

Other medicines and Vecuronium bromide

Tell your anaesthetist if you are taking, have recently taken or might take any other medicines. This includes medicines or herbal products that you have bought without a prescription. Vecuronium bromide may affect other medicines or be affected by them.

Medicines which increase the effect of Vecuronium bromide:

•    certain antibiotics;

•    certain medicines for heart disease or high blood pressure (water tablets, calcium channel blockers, beta-blockers and quinidine);

•    certain anti-inflammatory medicines (corticosteroids);

•    medicines for manic depressive illness (bipolar disorder);

•    magnesium salts;

•    the medicine called cimetidine, used to treat stomach ulcers, heartburn or acid reflux;

•    local anaesthetics (lidocaine);

•    medicines which cause increased volume of urine (diuretics).

Medicines which decrease the effect of Vecuronium bromide:

•    chronic use of medicines for epilepsy (phenytoin, carbamazepine);

•    calcium chloride and potassium chloride.

In addition, you may be given other medicines before or during surgery which can alter the effects of Vecuronium bromide. These include certain anaesthetics, other muscle relaxants, medicines such as phenytoin and medicines which reverse the effects of Vecuronium bromide. Vecuronium bromide may make certain anaesthetics work more quickly.

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

Pregnancy and breast-feeding

Tell your anaesthetist if you are pregnant or breastfeeding, 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.

Driving and using machines

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.

3. How Vecuronium bromide is given

Vecuronium bromide will be given to you by your anaesthetist. Vecuronium bromide is given intravenously (into a vein), either as single injections or as a continuous infusion (a drip).

The dose

Vecuronium bromide can be used in adults and children of all ages including infants and newborns. Your anaesthetist will work out the dose of Vecuronium bromide you need based on:

•    the type of anaesthetic

•    the expected length of the operation

•    other drugs you are taking

•    your state of health

•    your age.

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.

If you receive more Vecuronium bromide than you should

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 have any further questions on the use of this medicine, ask your anaesthetist or other doctor.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur while you are under anaesthetic, they will be seen and treated by your anaesthetist.

Uncommon (may affect up to 1 in 100 people)

•    the medicine is too effective, or not effective enough

•    the medicine works for longer than expected

•    lowering of blood pressure

•    increase in heart rate.

Very rare (may affect up to 1 in 10,000 people)

•    allergic (hypersensitivity) reactions (such as difficulty in breathing, collapse of the circulation and shock)

•    wheezing of the chest

•    muscle weakness

•    swelling, a rash or redness of the skin

•    pain near the site of injection.

Reporting of side effects

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 Yellow Card Scheme, Website: (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Vecuronium bromide

The hospital will keep Vecuronium bromide according to the correct storage conditions.

6.    Contents of the pack and other information

What Vecuronium bromide contains

-    The active substance is vecuronium bromide. Each vial contains 10 mg of vecuronium bromide. It is dissolved before use to make a solution.

-    The other ingredients are citric acid monohydrate, disodium phosphate dihydrate, mannitol, sodium hydroxide, and phosphoric acid.

What Vecuronium bromide looks like and contents of the pack

Vecuronium bromide is a white powder for solution for injection.

There are 1, 10, 20, 20 (2x10) and 100 vials of Vecuronium bromide per pack.

Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: BRADEX S.A., Pharmaceutical Products, 27 Asklipiou str., GR-14568 Krioneri, Attiki, Greece,

Tel.: +30 2106221801, +30 2106220323,

Fax: +30 2106221802.

Manufacturer: DEMO SA Pharmaceutical Industry, 21^st km National Road Athens - Lamia,

14568 Krioneri, Attiki, Greece,

Tel: +30 210 8161802, Fax: +30 210 8161587.

This medicinal product is authorised in the Member States of the EEA under the following names:

United    Vecuronium bromide 10 mg

Kingdom:    Powder for solution for injection

Germany:    Vecuronium BRADEX 10 mg

Pulver zur Herstellung einer Injektionslosung

Portugal:    Brometo de Vecuronio Bradex

10 mg Po para solugao injectavel

This leaflet was last revised in 01/2016.

The following information is intended for healthcare professionals only:

Preparation and handling Reconstitution:

Vecuronium bromide 10 mg Addition of 5ml water for injections results in an isotonic solution of pH 4 containing 2 mg vecuronium bromide per ml. (2 mg/ml).

Alternatively, in order to obtain a solution with a lower concentration Vecuronium bromide 10 mg may be reconstituted with a volume up to 10 ml of the following infusion fluids:

•    5% glucose injection fluid

•    0.9% sodium chloride injection fluid

•    Lactated Ringer's solution

•    Lactated Ringer's injection and 5% glucose

•    Glucose 5% and 0.9% sodium chloride injection

•    Water for injections.

Chemical and physical in-use (i.e. following reconstitution) stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Compatibilities

When Vecuronium bromide is reconstituted with water for injections, the resultant solution can be mixed with the following infusion fluids, packed in PVC or glass, to a dilution up to 40 mg/litre:

•    0.9% NaCl solution

•    5% glucose solution

•    Ringer's solution

•    Ringer's glucose.

The above-mentioned reconstituted solution can also be injected in to the line of a running infusion of the following fluids:

•    Lactated Ringer's solution

•    Lactated Ringer's solution and 5% glucose

•    Glucose 5% and 0.9% sodium chloride solution

•    Haemaccel

•    Dextran-40 5% in 0.9% sodium chloride solution

•    Water for injections.

Compatibility studies with other infusion fluids have not been performed.

If this leaflet is difficult to see or read please contact the following address for help:

Athlone Laboratories, Ballymurray, Co. Roscommon, Ireland.

Tel: +353-9066-61109. Email: medical@athlone-laboratories.com.