Ronia ® 10 mg Solution

Rocuronium bromide belongs to a group of medicines called muscle relaxants. RONIA acts by blocking the impulses from the nerves to the muscles, thereby causing the muscles to relax. When you have an operation, your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation. RONIA may be used if you are receiving anaesthesia to ease the insertion of a tube into your trachea (windpipe) for artificial ventilation (mechanical assistance of breathing). RONIA may also be used as an adjunct in the intensive care unit (ICU) (e.g. to ease the insertion of a tube into your windpipe), for short term use. RONIA may be given to paediatric patients aged 28 days to 18 years (term infants to adolescents), as an adjunct to general anaesthesia to ease the insertion of a tube into the trachea (windpipe) of your child for artificial ventilation (mechanical assistance of breathing) and to relax the muscles.

RONIA should not be administered to you:

• if you are allergic (hypersensitive) to rocuronium bromide or the bromide ion, or any ingredient of RONIA (listed in section 6).
• RONIA is contraindicated in new-born babies (up to 1 month old) and is not recommended in the facilitation of mechanical ventilation in the intensive care in children and elderly patients (older than 65 years).

Warnings and precautions

Tell your doctor or healthcare professional before being given RONIA:

• if you are allergic to any muscle relaxant
• if your liver does not work well or you have a biliary disease
• if your kidneys do not work well
• if you have heart disease or a disease affecting your blood circulation
• if you take or used corticosteroids (medicines for inflammation). Myopathy (a disease of muscle tissue) may occur if these medicines are used together with RONIA
• if you have a disease affecting the nerves and muscles (neuromuscular diseases, e.g. polio, myasthenia gravis or Eaton-Lambert syndrome)
• if you have burnt your skin
• if you have a low potassium level in the blood (hypokalaemia). Some causes may be severe vomiting, diarrhoea or diuretic therapy
• if you have a low calcium level in the blood (hypocalcaemia)
• if you have a high magnesium level in the blood (hypermagnesaemia)
• if you have low levels of proteins in the blood (hypoproteinaemia)
• if you suffer from dehydration (you use or lose more fluid than you take in)
• if you have an increased amount of acids in the blood (acidosis)
• if you have an increased amount of carbon dioxide in the blood (hypercapnia)
• if you suffer from excessive loss of weight (cachexia)

Prolonged paralysis and/or muscle weakness may occur in some patients (see POSSIBLE SIDE EFFECTS). You will be carefully observed in hospital, during and after the operation.

Children

There is inadequate data to support the use of RONIA in neonates (0 to 1 month).

Other medicines and RONIA

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Please tell your doctor or pharmacist if you are taking, or have recently taken or used:

• Corticosteroids (such as dexamethasone in the long-term use for asthma or inflammation)
• Antibiotics, such as lincomycin, clindamycin and penicillins
• Lithium (may be used for certain psychiatric disorders)
• Local anaesthetics such as lidocaine or bupivacaine
• Medicines used for the treatment of heart disease (such as quinidine) or high blood pressure (such as calcium channel blocking medicines or beta-blockers)
• Diuretics or “water pills” (medicines which increase the amount of urine)
• Magnesium salts (laxatives or diet supplements)
• Quinine (used for malaria)
• Medicines used for epilepsy treatment (such as phenytoin, carbamazepine)
• Potassium chloride
• Calcium chloride
• Protease inhibitors, such as gabexate and ulinastatin (medicines used for the treatment or prevention of a viral infection)
• Neostigmine or pyridostigmine (medicines used for the treatment of myasthenia gravis).

You may be given other medicines during the procedure which can influence the effects of RONIA. These may include certain anaesthetics (such as local anaesthetics or inhalational anaesthetics), other muscle relaxants. Your doctor will take this into account when deciding on a suitable dose of RONIA for you.

Pregnancy and breastfeeding

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 RONIA is administered to you. RONIA should not be given to pregnant or nursing women, as safety of its use in pregnancy and breastfeeding has not been established. RONIA may be given during Caesarean section.

Driving and using machines

RONIA can significantly affect your ability to drive a vehicle or to use machines (see POSSIBLE SIDE EFFECTS). Do not drive a vehicle or use potentially dangerous machines during the first 24 hours. Ask a responsible adult to take you home after your treatment. Ask your doctor when you can start driving and using machines again.

You will not be expected to give yourself RONIA. It will be given to you by a person who is qualified to do so (an anaesthetist). RONIA is given to you intravenously, either as a single injection or as a continuous infusion (over a longer period) into a vein. The usual dose is 0,6 mg per kg body weight and its effect will last 30 to 40 minutes. Your anaesthetist will ensure that you receive the correct dose. It depends on many factors, such as medicine interactions (their cross activity), the estimated length of surgery as well as your age and clinical condition. During the surgery the effect of RONIA is controlled continuously.

Use in children and adolescents (0 - ˂ 18 years of age): RONIA may be given to infants (28 days to 23 months), children (2 to 14 years) and adolescents (12 to 18 years). There is inadequate data to support the use of RONIA in neonates (0 to 1 month). The dose and its effect in children are similar to those in adults, but the anaesthetist will adjust the dose according to the needs of your child. Your doctor will consider if higher infusion rates might be necessary. Your doctor will tell you how long your treatment with RONIA will last. If you have the impression that the effect of RONIA is too strong or too weak, tell your doctor or pharmacist.

If you receive more RONIA than you should Since a healthcare professional will administer RONIA, he/she will control the dosage. However, in the event of over-dosage your doctor will manage the over-dosage. Your anaesthetist will carefully monitor your pulse rate, temperature, rate of breathing and blood pressure while you are treated with RONIA, therefore it is unlikely that you will be given too much RONIA.

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

If any of the following happens, tell your doctor immediately:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Welts, urticaria (hives), red skin, widespread severe rash and itching. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to RONIA. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Less frequent side effects

• Loss of movement (paralysis)
• Quicker than usual heartbeat (tachycardia)
• Increased level of histamine in the blood
• Lowering of blood pressure (hypotension)
• Failure of circulation (circulatory collapse and shock)
• Flushing
• Wheezing (bronchospasm)
• Itching or rash
• Muscle weakness, which may be worse if you have been treated with corticosteroids. See “Other medicines and RONIA”.
• Prolonged effect of muscle relaxation (prolonged neuromuscular block)
• Pain and redness at the injection site
• Breathing (respiratory) failure
• Temporary cessation of breathing (apnoea)

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 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 RONIA.

Store all medicines out of reach of children. RONIA is stored in a refrigerator (2 - 8 ºC) in the hospital and protected from light. Do not freeze. RONIA may be stored outside the refrigerator at a temperature of up to 25 °C for a maximum of 12 weeks, after which it should be discarded. RONIA should not be placed back in the refrigerator, once it has been kept outside. The storage period must not exceed the shelf life.

After dilution: From a microbiological point of view, the diluted product should therefore be used immediately after opening the vial. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC, unless dilution has taken place in controlled and validated aseptic conditions. Any unused solutions should be discarded. Do not use RONIA if you notice the solution is not clear or free from particles. Do not use after the expiry date stated on the label and carton. Return all unused medicines to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).