Rocuronium Bromide Medsurge

Rocuronium Bromide Medsurge

Active ingredient: rocuronium bromide

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Rocuronium Bromide. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Rocuronium Bromide.

Where to find information in this leaflet:

1. Why am I using Rocuronium Bromide Medsurge?
2. What should I know before I use Rocuronium Bromide Medsurge?
3. What if I am taking other medicines?
4. How do I use Rocuronium Bromide Medsurge?
5. What should I know while using Rocuronium Bromide Medsurge?
6. Are there any side effects?
7. Product details

1. Why am I using Rocuronium Bromide Medsurge?

Rocuronium Bromide Medsurge contains the active ingredient rocuronium bromide. Rocuronium Bromide is one of a group of medicines called muscle relaxants.

Rocuronium Bromide is used during an operation as part of the 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 the nerves send messages to the muscles by impulses. Rocuronium bromide acts by blocking these impulses so the muscles are relaxed. Because the muscles needed for breathing also become relaxed you will need help with your breathing (artificial respiration) during and after your operation until you can breathe on your own. During the operation the effect of the muscle relaxant is constantly checked and if necessary some more drug is given. At the end of the operation the effects of Rocuronium bromide are allowed to wear off and you can start breathing on your own. Sometimes another drug is given to help speed this up. Rocuronium bromide can also be used in Intensive Care to keep your muscles relaxed.

Ask your doctor if you want any more information about this medicine.

Rocuronium bromide is not addictive.

2. What should I know before I use Rocuronium Bromide Medsurge?

Warnings

If you are going to have an operation it is important that you discuss the following points with your doctor, since it can influence the way Rocuronium Bromide is given to you.

Do not use Rocuronium Bromide if:

• you are allergic to rocuronium bromide, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Check with your doctor if you:

• have/had any other medical conditions especially the following:
  – an allergy to muscle relaxants
  – kidney disease
  – liver or gallbladder disease
  – a heart disease
  – diseases affecting nerves or muscles
  – oedema (local or generalised swelling due to fluid)
• have any medical conditions that may affect how Rocuronium Bromide works:
  – low potassium levels in the blood
  – high magnesium levels in the blood
  – low calcium levels in the blood
  – low levels of protein in the blood
  – dehydration
  – too much acid in the blood
  – too much carbon dioxide in the blood
  – general ill-health
  – overweight
  – burns

If you are suffering from any of these conditions your doctor will take this into account when deciding the correct dose of Rocuronium Bromide for you.

• take any medicines for any other condition
• have allergies to any other medicines

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the risks and benefits of using Rocuronium bromide if you are pregnant or breast-feeding.

Children/Elderly

Rocuronium bromide can be used in term newborn infants (0-28 days), infants (28 days-23 months), children (2-11 years), adolescents (12-18 years) and elderly patients but your doctor should first assess your medical history.

Elderly (65 years and older) may be at an increased risk of residual paralysis.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Rocuronium Bromide and affect how it works.

Medicines that may increase the effect of Rocuronium Bromide include:

• anaesthetics, medicines to make you sleep during surgery
• long term concurrent use of corticosteroids (anti-inflammatory medicines) and Rocuronium bromide in the Intensive Care Unit
• antibiotics
• lithium, a medicine used to treat bipolar disorder
• quinidine, calcium channel blockers, beta-blockers and diuretics (fluid tablets) (medicines used to treat heart disease or high blood pressure)
• quinine (a medicine used to treat malaria)
• magnesium salts
• lidocaine (lignocaine) and bupivacaine hydrochloride (local anaesthetics)
• use of phenytoin (medicines used to treat epilepsy) during operation

Medicines that may reduce the effect of Rocuronium Bromide include:

• long term use of carbamazepine and phenytoin (medicines used to treat epilepsy)

Medicines that have variable effect of Rocuronium Bromide include:

• other muscle relaxants

Rocuronium Bromide may influence the effects of the following medicines:

• the effect of local anaesthetics (lidocaine) may be increased

You may need to use different amounts of your medicines or take different medicines. Your doctor will advise you.

If you are taking magnesium sulfate to treat toxaemia of pregnancy (preeclampsia), tell your doctor as the dose of Rocuronium Bromide may need to be reduced.

Your doctor will have a complete list of medicines that may cause problems when used with Rocuronium Bromide.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Rocuronium Bromide.

4. How do I use Rocuronium Bromide Medsurge?

How much to take / use

• The doctor will determine the dose. The usual dose is 0.6 mg rocuronium bromide per kg body weight and the effect lasts 30-40 minutes. During the operation your doctor will check whether Rocuronium Bromide is still working. You may be given additional doses if they are needed.

When to take / use Rocuronium Bromide

• Rocuronium Bromide will be given by a doctor. It will not be given to you until you are asleep from the anaesthetic.
• It will be injected into a vein before and/or during an operation. It will be given as a single injection or continuous infusion

If you use too much Rocuronium Bromide

As Rocuronium bromide doses are carefully worked out and are given by a doctor experienced in its use, it is extremely unlikely that you will be given too much Rocuronium bromide. However, if this does happen, your doctor will make sure that you continue breathing artificially until you can breathe on your own again. Your doctor may speed-up your recovery by giving you a drug that reverses the effects of Rocuronium bromide.

5. What should I know while using Rocuronium Bromide Medsurge?

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Rocuronium Bromide affects you.

Your doctor will tell you when it is safe to drive and operate potentially dangerous machinery after you have been given Rocuronium bromide.

Looking after your medicine

Rocuronium bromide is stored in the hospital.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
flushing pain at injection site irritation at injection site red skin rash or itchy rash	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Signs and symptoms of cardiovascular problems: fast heartbeat dizziness, light-headedness (low blood pressure) Signs and symptoms of muscle problems: muscle weakness or paralysis aching muscles or weakness, not caused by exercise Signs and symptoms of lung problems: wheezing, coughing difficulty breathing Signs and symptoms of allergic reactions: rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing sudden signs of allergy such as rash, itching, hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing severe allergic coronary blood vessels spasm (Kounis syndrome) resulting in chest pain (angina) or heart attack (myocardial infarction) Signs and symptoms of problems in other organs: sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and/or weakness in your muscles Dilated pupils (mydriasis) or fixed pupils

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects after being discharged from the hospital.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Rocuronium Bromide Medsurge contains

Active ingredient (main ingredient)	Rocuronium bromide
Other ingredients (inactive ingredients)	sodium acetate sodium chloride glacial acetic acid water for injections

No preservative has been added.

Do not take this medicine if you are allergic to any of these ingredients.

What Rocuronium Bromide Medsurge looks like

Rocuronium Bromide is a clear, colourless to faintly yellow solution in glass vials.

Rocuronium bromide is available as: 50 mg/ 5 mL injection solution, pack of 10 vials (AUST R 349871).

Who distributes Rocuronium Bromide Medsurge

Medsurge Pharma Pty Ltd
Unit 1&2, 6-7 Gilda Court
Mulgrave, Victoria 3170

Marketed and distributed by Medsurge Healthcare.
Telephone: 1300 788 261
Website: www.medsurgehc.com

This leaflet was prepared in January 2024.