Versudex 100 mg Solution

VERSUDEX belongs to a group of medicines called selective relaxant binding medicines.
When you have some types of operations, your muscles must be completely relaxed. This makes it easier for the surgeon to do the operation. For this, the general anaesthetic you are given includes medicines to make your muscles relax. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again. VERSUDEX is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier. It does this by combining with the rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used and in children above 7 years of age when rocuronium bromide is used for a moderate level of relaxation.

VERSUDEX should not be administered to you :
• if you are hypersensitive (allergic) to sugammadex or any of the other ingredients of VERSUDEX (listed in section 6).
Warnings and precautions
Tell your doctor or healthcare provider before being given the injection:
• if you have kidney conditions or had kidney conditions in the past. This is important as VERSUDEX is removed from your body by the kidneys,
• if you have diseases which cause an increased risk of bleeding (disturbances of blood clotting) or if you are taking medicines to prevent your blood from clotting (anticoagulation medicine) (see Other medicines and VERSUDEX),
• if you have heart conditions, if you are elderly, or if you have fluid retention (oedema), as you may experience longer recovery times,
• if you have liver conditions or had liver conditions in the past.
Children
There is no experience with VERSUDEX in children younger than 7 years of age and in neonates. VERSUDEX is not recommended for use in children and neonates.
Other medicines and VERSUDEX
Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:
• Toremifene: medicines used to treat breast cancer.
• Fusidic acid: medicines used to treat bacterial infections.
• Contraceptives: medicines used in family planning. VERSUDEX can make hormonal contraceptives (including the ‘pill’, vaginal ring, implants or a hormonal intrauterine system (IUS)) less effective because it reduces how much you get of the progestogen hormone.
• In general, VERSUDEX does not have an effect on laboratory tests. However, it may affect the results of a blood test for a hormone called progesterone. Talk to your doctor if your progesterone levels need to be tested on the same day you receive VERSUDEX.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine.
Driving and using machines
VERSUDEX has no known influence on the ability to drive and use machines. It is not always possible to predict to what extent VERSUDEX may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which VERSUDEX affects you (see section 4).

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself VERSUDEX. It will be given to you by a person who is qualified to do so. Your doctor will determine the required dosage based on your condition. Your doctor will tell you how long your treatment with VERSUDEX will last.
If you receive more VERSUDEX than you should
Since a healthcare provider will administer VERSUDEX, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.
If you forget to use VERSUDEX
Since a healthcare provider will administer VERSUDEX, it is unlikely that the dose will be missed.

VERSUDEX can have side effects. Not all side effects reported for VERSUDEX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VERSUDEX, please consult your healthcare provider for advice.
If any of the following happens, stop using VERSUDEX and tell your doctor immediately or go to the casualty department at your nearest hospital:
• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.
These are all very serious side effects. If you have them, you may have had a serious reaction to VERSUDEX. You may need urgent medical attention or hospitalisation.
If these side effects occur while you are under anaesthesia, they will be seen and treated by your anaesthetist.
Tell your doctor if you notice any of the following:
Frequent side effects:
• changes in taste (dysgeusia),
• cough,
• airway difficulties that may include coughing, sore throat, muscle spasms in your throat,
• complications during your procedure such as changes in heart rate, coughing or moving,
• low blood pressure (hypotension).
Side effects with an unknown frequency:
• changes in the way your heart beats (bradycardia, tachycardia),
• nausea,
• redness of the skin (flushing).
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to:
SAHPRA: https://www.sahpra.org.za/health-products-vigilance/
Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088
By reporting side effects, you can help provide more information on the safety of VERSUDEX.

Store all medicines out of reach of children. Store at or below 25 ºC. Do not freeze. Keep the vial in the outer carton in order to protect from light. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).