Rocuronium Bromide 10 Mg/Ml Solution For Injection/Infusion
Package leaflet: Information for the user
Rocuronium bromide 10 mg/ml solution for injection/infusion
Rocuronium Bromide
Read all of this leaflet carefully before you start using 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 doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Rocuronium bromide is and what it is used for
2. What you need to know before you use Rocuronium bromide
3. How to use Rocuronium bromide
4. Possible side effects
5. How to store Rocuronium bromide
6. Contents of the pack and other information
1. What Rocuronium bromide is and what it is used for
Rocuronium bromide belongs to a group of medicines called muscle relaxants.
Normally the nerves send messages to the muscles by impulses. Rocuronium bromide acts by blocking these impulses so that the muscles become relaxed.
When you have an operation your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.
Rocuronium bromide may also be used if you are having anaesthesia to ease the insertion of a tube into your trachea (windpipe) for artificial ventilation (mechanical assistance of breathing).
Your doctor may also use this medicine as an adjunct in the intensive care unit (ICU) (e.g. to ease the insertion of a tube into your windpipe).
Children and adolescents
This medicine may be given to paediatric patients aged 0 to <18 years (term neonates 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.
2. What you need to know before you use Rocuronium bromide Do not use Rocuronium bromide:
- if you are allergic to rocuronium bromide, the bromide ion or any of the other ingredients of this medicine (listed in section 6).
Warning and precautions
Talk to your doctor, pharmacist or nurse before using Rocuronium bromide:
- if you are allergic to any muscle relaxant
- if you have a kidney, a liver or a biliary disease
- if you have a heart disease or a disease affecting your blood circulation
- if you have oedema (an accumulation of fluid beneath the skin, e.g. in the ankle area)
- if you have a disease affecting the nerves and muscles (neuromuscular diseases, e.g. polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)
- if you ever developed a drop in body temperature during anaesthesia (hypothermia)
- if you ever developed a severe fever (malignant hyperthermia) during anaesthesia
- if you have a fever
- if you have a low calcium level in the blood (hypocalcaemia), caused for example by massive transfusions
- if you have a low potassium level in the blood (hypokalaemia), caused for example by severe vomiting, diarrhoea or diuretic therapy
- if you have a high magnesium level in the blood (hypermagnesaemia)
- if you have a low level of proteins in the blood (hypoproteinaemia)
- if you suffer from dehydration (the loss of water and fluids essential for normal body function)
- 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 tend to overbreathe (hyperventilation). Overbreathing leads to too little carbon dioxide in the blood (alkalosis).
- if you suffer from excessive loss of weight (cachexia)
- if you are overweight or elderly
- if you have burns
Other medicines and Rocuronium bromide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, such as:
- antibiotics
- anti-depressants: medicines used to treat depression (e.g. MAO inhibitors)
- medicines used for the treatment of heart diseases or high blood pressure (e.g. quinidine, calcium channel blocking agents, adrenergic blocking agents (e.g. beta blockers)
- diuretics or water pills (medicines which increase the amount of urine),
- some laxatives such as magnesium salts
- quinine (used to treat pain and infections)
- medicines used for epilepsy treatment (e.g. phenytoine, carbamazepine)
- corticosteriods
- medicines used for the treatment of myastenia gravis (neostigmine, pyridostigmin),
- vitamin B1 (thiamine)
- azathioprin (used for transplant rejection prevention and treatment of auto-immune diseases)
- theophylline (used for the treatment of asthma)
- noradrenaline (a hormone which impacts blood pressure and other body functions)
- potassium chloride
- calcium chloride
- medicines used for the treatment or prevention of a virus infection (protease inhibitors)
Please note:
You may be given other medicines during the procedure which can influence the effects of Rocuronium bromide. These include certain anaesthetics (e.g. local anaesthetics, inhalation anaesthetics), other muscle relaxants, protamines which reverse the anticoagulant effect (prevention of blood clots) of heparin. Your doctor will take this into account when he is deciding the correct dose of this medicine for you.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
There are very limited data on the use of Rocuronium bromide during human pregnancy and no data on breast-feeding women. Rocuronium bromide should only be given to pregnant and nursing women when the doctor decides that the benefits outweigh the risks.
This medicine may be given during Caesarian section.
There are no data available on the influence of this medicine on your fertility.
Driving and using machines
Rocuronium bromide has a major influence on driving and using machines.
Therefore, it is not recommended to drive a car or use potentially dangerous machines during the first 24 hours.
Your doctor should advise you when you can start driving and using machines again. You should always be accompanied home by a responsible adult after your treatment.
Rocuronium bromide contains sodium
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodium free’.
3. How to use Rocuronium bromide
Rocuronium will be given to you by your anaesthetist. It is given to you intravenously either as a single injection or as a continous infusion (over a longer period of time) into a vein. The usual dose is 0.6 mg per kg body weight and its effect will last 30 to 40 minutes. During the surgery the effect of Rocuronium bromide is controlled continuously.
If necessary, additional doses could be administered to you. The dose is adjusted to your needs by your anaesthetist. It depends on many factors, such as medicine interactions (their cross activity), taking into consideration the estimated length of surgery as well as your age and clinical condition.
Use in children and adolescents
This medicine may be given to neonates (0 - 28 days), infants (28 days to < 3 months) and toddlers (> 3 months to < 2), children (2-11 years) and adolescents (12 to < 17 years).
The anesthetist will adjust the dose according to the needs of your child. Your doctor will take into account that for children higher infusion rates might be necessary.
The experience with rocuronium bromide in a special type of anaestetic technique called ‘rapid sequence induction’ is limited in paediatric patients. Therefore, this medicine is not recommended for this purpose in paediatric patients.
If you are given more Rocuronium bromide than you should
As your anaesthetist will be monitoring your conditions during the procedure it is unlikely that you will be given too much Rocuronium bromide. However, if this happens and your lungs are not working, your anaesthetist will make sure that you continue breathing artificially until you can breathe on your own. You may need to be kept asleep while recovery takes place however this is not unusual.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions (allergic reactions) are rare, ie. they may affect up to 1 in 1,000 people but may be life-threatening. A hypersensitivity reaction may include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue.
Please inform your doctor or nurse immediately if one or more of these reactions occur.
Other possible side effects include:
Very common (may affect more than 1 in 10 people):
- Pain at the injection site
Very rare (may affect up to 1 in 10,000 people):
- Increased level of histamine in the blood
- Increase in heart rate (tachycardia)*
- Wheezing (bronchospasm)
- Itching or rash
- Wide spread, severe rash (exanthema)
- Prolonged effect of muscle relaxation (prolonged neuromuscular block)
- Lowering of blood pressure (hypotension)
- Welts (angioedema)
- Hives (urticaria)
- Loss of movement (paralysis)
- Failure of circulation (circulatory collapse and shock)
- Anaphylactic reaction/shock (a life-threatening allergic reaction)
* Clinical studies suggest that in paediatric patients an increase in heart rate is common and may affect up to 1 in 10 people.
Not known (frequency cannot be estimated from the available data):
- Breathing (respiratory) failure
- Stop breathing (apnoea)
- Muscle weakness
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Rocuronium Bromide
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial, after ‘EXP.’. The expiry date refers to the last day of that month.
Before opening: Store in a refrigerator (2-8°C).
Storage out of the refrigerator:
This medicine may also be stored outside of the refrigerator at a temperature of up to 25°C for a maximum 12 weeks, after which it should be discarded. The product should not be placed back into the refrigerator, once it has been kept outside. The storage period must not exceed the shelf-life.
After dilution: Chemical and physical in-use stability has been demonstrated for 72 hours at 30oC. From a microbiological point of view, the diluted product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user/administrator and would normally not be longer than 24 hours at 2 to 8oC, unless dilution has taken place in controlled and validated aseptic conditions.
For single use only.
Do not use Rocuronium bromide if you notice any particles or visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Rocuronium bromide contains
- The active ingredient is rocuronium bromide.
Each ml of solution for injection/infusion contains 10 mg of rocuronium bromide.
Each 5 ml vial contains 50 mg rocuronium bromide.
- The other ingredients are sodium acetate trihydrate, acetic acid (glacial), sodium chloride, sodium hydroxide and water for injections.
What Rocuronium bromide looks like and contents of the pack
Rocuronium bromide is a clear colorless to yellow or orange solution. The solution is supplied in tubular glass vials with a rubber closure and yellow flip off aluminium seal.
Rocuronium bromide is available in packs of 10 vials containing 5ml solution.
Marketing Authorisation Holder
Mylan,
Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000 Malta.
This leaflet was last revised in 10/2014
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The following information is intended for medicinal or healthcare professionals only:
PREPARATION GUIDE FOR USE WITH
Rocuronium bromide 10 mg/ml Solution for injection/infusion
Rocuronium bromide is administered intravenously (i.v.) either as a bolus injection or as a continuous infusion. Administration should be begun immediately after mixing, and should be completed within 24 hours.
Rocuronium bromide should be administered only by experienced staff familiar with the use of neuromuscular blocking agents. Adequate facilities and staff for endotracheal intubation and artificial ventilation have to be available for immediate use.
Incompatibilities
Physical incompatibility has been documented for Rocuronium bromide when added to solutions containing the following active substance:
Amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, methohexital, methylprednisolone, prednisolone sodium succinate, thiopental, trimethoprim and vancomycin.
This medicinal product must not be mixed with other medicinal products except those mentioned in the following sections.
Mixture with other products:
Rocuronium bromide has been shown to be compatible with: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), glucose 50 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%), water for injections, Lactated Ringers solution and Haemaccel for in-use concentrations of 0.5 mg/ml and 2 mg/ml.
If Rocuronium bromide is administered via the same infusion line with other medicinal products, it is important that the infusion line is adequately flushed (e.g. with sodium chloride 9 mg/ml (0.9 %) solution for infusion) between administration of Rocuronium bromide and medicinal products for which incompatibility with Rocuronium bromide has been demonstrated or for which compatibility with Rocuronium bromide has not been established.
Shelf-life
Unopened vial: 18 months
After dilution: Chemical and physical in-use stability has been demonstrated for 72 hours at 30°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user/administrator and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Storage information
Before opening: Store in a refrigerator (2-8°C)
Storage out of the refrigerator:
Rocuronium bromide solution for injection may also be stored outside of the refrigerator at a temperature of up to 25°C for a maximum 12 weeks, after which it should be discarded. The product should not be placed back into the refrigerator, once it has been kept outside. The storage period must not exceed the shelf-life.
Special precautions for handling
For Intravenous use only as a bolus injection or as a continuous infusion.
Administration should be begun immediately after mixing, and should be completed within 24 hours.
This medicinal product is for single use only, any unused solutions should be discarded.
The solution is to be visually inspected prior to use. Only clear solutions free from particles should be used.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.