Muscuron 4 mg Injection

MUSCURON contains the active substance vecuronium bromide. MUSCURON is used as a muscle relaxants during anaesthesia and surgery.

MUSCURON should not be administered to you:

• If you are hypersensitive (allergic) to vecuronium bromide or bromide ion or any of the ingredients of MUSCURON (listed in section 6).
• The safety and efficacy of MUSCURON injection in children 3 months or younger have not been established.
• The safety in pregnancy and lactation has not been established.

Warnings and precautions

Tell your doctor or health care provider before being given MUSCURON.

• if you have a heart disease or an underlying disease that affects your blood circulation
• if you are allergic to MUSCURON or any muscle relaxants.
• if you have diseases affecting nerves and muscles (poliomyelitis, myasthenia gravis, Eaton Lambert syndrome)
• MUSCURON can cause respiratory paralysis. Some conditions may influence the effects of MUSCURON
• if you suffer from severe kidney disease.
• if you are overweight (obesity)
• if your body temperature drops below normal (hypothermia).
• if you have low levels of potassium in the blood (hypokalaemia, caused by severe vomiting and diarrhoea).
• if you have burns.
• if you have high levels of magnesium in the blood. (hypermagnesaemia).
• if you have low levels of calcium in the blood after blood transfusion.
• if you have low levels of proteins in the blood.
• loss too much water from the body (dehydration)
• if you have too much acid the blood or body tissue (acidosis)
• an increase level of carbon dioxide in the blood (hypercapnia)
• if you have a disease that causes extreme weight loss and muscle wasting (cachexia).

Children and adolescents

The safety and efficacy of Muscuron injection in children 3 months or younger have not been established.

Other medicines and MUSCURON

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Medicines which increases the effect of Vecuronium:

• certain medicines used to make you sleep during surgery (anaesthetics; for example ether, isoflurance, methoxyflurane, cyclopropane, halothane, enflurane, suxamethonium)
• certain medicines to treat bacterial infections (antibiotics; for example aminoglycosides, lincosamide and polypeptide antibiotics, acylamino-penicillin antibiotics)
• medicines which increase the amount of urine (diuretics or water tablets)
• medicines used for the treatment of heart disease or high blood pressure (calcium channel blockers, beta-blockers and quinidine)
• medicines used to treat mania, manic depressive illness or depression (lithium salts)
• certain medicines used to treat stomach ulcers, heartburn or acid reflux (cimetidine)
• some laxatives such as magnesium salts
• long-term concomitant use of certain anti-inflammatory medicines (corticosteroids)
• 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 MUSCURON

• certain medicines used for epilepsy (for example phenytoin or carbamazepine)
• calcium chloride and potassium chloride.

Effect of MUSCURON on other medicines

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

You will not be expected to give yourself MUSCURON. It will be given to you by a person who is qualified to do so. MUSCURON injection will be administered in a vein by a medical professional during surgery. The dose will depend on your body weight and the response required by your doctor.

If you take more MUSCURON than you should

Since a health care provider will administer MUSCURON, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take MUSCURON

Since a health care provider will administer MUSCURON, it is unlikely that the dose will be missed.

MUSCURON can have side effects. Not all side effects reported for MUSCURON are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving MUSCURON, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MUSCURON. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Uncommon/Less frequent side effects:

• muscle weakness or paralysis
• failure of circulation (circulatory collapse and shock)
• tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
• rapid swelling under the skin (angioneurotic oedema)
• rash or redness of the skin (erythematous rash)
• pain near the site of injection
• airway complication of anaesthesia
• longer than usual muscle disorder usually seen after the use of MUSCURON in combination with steroids (corticosteroids including an inflammatory effect) in severe ill patients (steroid myopathy).

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 or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MUSCURON.

• Store at or below 25 °C.
• Reconstituted solution containing 2 mg/mL of MUSCURON is stable for 24 hours, stored at or below 25°C.
• Store all medicines out of reach of children.
• Protect from light. Do not freeze.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label / carton / bottle.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).