10 mg / ml Solution for injection / infusion
What Rocuronium Fresenius Kabi is and what it is used for
Rocuronium Fresenius Kabi belongs to a group of medicines called muscle relaxants.
Normally, the nerves send messages to the muscles in the form of electrical impulses. Rocuronium Fresenius Kabi works by blocking these impulses so that the muscles become relaxed.
If you are having surgery, your muscles must be completely relaxed. This makes it easier for the surgeon to operate.
Rocuronium Fresenius Kabi can also be used if you are anesthetized to make it easier to insert a tube into the trachea for artificial ventilation (mechanical breathing assistance).
Rocuronium Fresenius Kabi is intended for use in adults as well as in newborns (0‑27 days), infants and young children aged 28 days ‑ 23 months, children aged 2‑11 years, and adolescents aged 12‑17 years.
In adults, Rocuronium Fresenius Kabi can also be used for short-term treatment as an aid in the intensive care unit (eg to make it easier to insert a tube into the trachea).
Rocuronium bromide contained in Rocuronium Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Rocuronium Fresenius Kabi
Do not use Rocuronium Fresenius Kabi
- if you are allergic to rocuronium bromide, bromide, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse if you have or have had any of the following:
- if you are allergic to any muscle relaxant,
- if you have kidney, liver, or gallbladder disease,
- if you have a heart condition or a disease that affects your blood circulation,
- if you have swelling due to fluid retention (eg at the ankles),
- if you have a disease that affects nerves and muscles (neuromuscular diseases, such as polio, myasthenia gravis, or myasthenic syndrome (Eaton-Lambert)),
- if you have ever had too low a body temperature during anesthesia ( hypothermia ) if you have previously had malignant hyperthermia (sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and/or weakness in the muscles)
- if you have a fever,
- if you have low blood calcium (hypocalcemia), (eg due to massive blood transfusions ),
- if you have low blood potassium ( hypokalaemia ), (caused eg by severe vomiting, diarrhea, or diuretic treatment),
- if you have high levels of magnesium in your blood (hypermagnesemia),
- if you have low levels of protein in your blood (hypoproteinemia),
- if you suffer from dehydration,
- if you have an elevated level of acid in your blood ( acidosis ),
- if you have elevated levels of carbon dioxide in your blood ( hypercapnia ),
- if you tend to breathe too violently (hyperventilate), Hyperventilation produces too low a level of carbon dioxide in the blood ( alkalosis ).
- if you have lost a lot of weight ( cachexia ),
- if you are overweight or elderly ,
- if you have burned.
Other medicines and Rocuronium Fresenius Kabi
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, such as:
- antidepressant drugs: drugs used to treat depression (eg lithium, MAO inhibitors ),
- drugs used to treat heart disease or high blood pressure (eg quinidine, calcium channel blockers, adrenergic blockers (eg beta-blockers ),
- diuretics or diuretics (medicines that increase the amount of urine),
- certain laxatives, e.g. magnesium salts,
- quinine (used to treat pain and infection ),
- medicines used to treat epilepsy (eg phenytoin, carbamazepine),
- corticosteroid is,
- drugs used to treat myasthenia gravis (neostigmine, pyridostigmine),
- vitamin B 1 ( thiamine ),
- azathioprine (used to prevent rejection after transplantation and to treat autoimmune diseases),
- theophylline (used to treat asthma ),
- norepinephrine (a hormone that affects blood pressure and other bodily functions),
- potassium chloride,
- calcium chloride,
- medicines used to treat or prevent viral infections (protease inhibitors: gabexat, ulinastatin).
You may be given other medicines during the procedure that may affect the effects of rocuronium. This applies to certain drugs for anesthesia and anesthesia (eg local anesthetics, inhaled drugs for anesthesia) and other muscle relaxants, protamines that reverse the anticoagulant effect (prevent blood clots) of heparin. Your doctor will take this into account when deciding on the correct dose of rocuronium for you.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are no clinical data available on the use of rocuronium bromide during pregnancy and lactation. Rocuronium Fresenius Kabi should be given to pregnant and lactating women only if the doctor decides that the benefits outweigh the risks. Rocuronium Fresenius Kabi can be given by cesarean section. Breast-feeding should be discontinued for 6 hours after using this medicine.
Driving and using machines
Rocuronium Fresenius Kabi has a major impact on the ability to drive and use machines.
Your doctor will tell you when you can start driving and using machines again. Anyone treated with Rocuronium Fresenius Kabi should always be followed home by an adult.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rocuronium Fresenius Kabi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial (2.5 ml, 5 ml, 10 ml), ie essentially ‘sodium-free’.
How to use Rocuronium Fresenius Kabi
Rocuronium Fresenius Kabi is given to you by an anesthesiologist (a doctor who specializes in, among other things, anesthesia and anesthesia). It is given intravenously either as a single injection or as a continuous infusion (over a long period) into a vein.
The usual dose is 0.6 mg per kg body weight and its effect lasts for 30 to 40 minutes. During the operation, the effect of Rocuronium Fresenius Kabi is continuously monitored.
If necessary, you will receive an additional dose. The anesthesiologist adjusts the dose to your needs. The need depends on many factors, e.g. concomitant use of other drugs (drug cross-activity), taking into account the duration of the surgery and your age and clinical condition.
Rocuronium Fresenius Kabi is not recommended as a supplement in intensive care for children and elderly patients.
Use for children and adolescents:
For neonates (0‑27 days), infants and young children (28 days ‑ 23 months), children (2‑11 years), and adolescents (12‑17 years), the recommended dose is the same as for adults, except for continuous infusion rate in children (2‑11 years), which may be higher than in adults. The anesthetist will adjust the infusion rate according to the child’s needs.
Experience with rocuronium bromide in a special type of drug technique called “rapid induction” is limited for children and adolescents. Rocuronium bromide is therefore not recommended for use in children and adolescents.
If you use more Rocuronium Fresenius Kabi than you should
The anesthesiologist monitors you closely while you are being treated with Rocuronium Fresenius Kabi, therefore it is unlikely that you will receive too much Rocuronium Fresenius Kabi. If this occurs, the anesthesiologist will ensure that anesthesia and mechanical breathing assistance continue until you breathe on your own.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Information for healthcare professionals can be found in the corresponding section below.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions (anaphylactic reactions/shock) are very rare but can be life-threatening allergic reactions. A hypersensitivity reaction can manifest itself as a rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
Tell your doctor or nurse immediately if you get any of these reactions.
Uncommon (may affect up to 1 in 100 people) / Rare (may affect up to 1 in 1000 people):
- Pain at the injection site
- The effect of the drug is too high, too low, or absent
- The drug works longer than expected (prolonged neuromuscular blockade)
- The drug prolongs anesthesia (prolonged recovery from anesthesia )
- Lowering of blood pressure ( hypotension )
- Increased heart rate ( tachycardia )
Very rare (may affect up to 1 in 10,000 people):
- Increased histamine levels in the blood (a substance that triggers allergic reactions)
- Breathe with a hissing sound ( bronchospasm )
- Rash, itching
- Redness of the face
- Swelling of the face (facial edema)
- Widespread, severe skin rash (exanthema, erythematous rash)
- Muscle weakness ( myopathy )
- Swelling ( angioedema )
- Urticaria _ _ _
- Paralysis (loose paralysis)
- Circulatory arrest (circulatory collapse and shock )
- Breathing difficulties (respiratory failure, apnea )
No known frequency (cannot be calculated from the available data):
- Respiratory failure
- Respiratory arrest ( apnea )
- Severe allergic reaction with convulsions in the coronary arteries of the heart (Kounis syndrome) leading to chest pain (angina) or heart attack
Children and adolescents:
In clinical trials with rocuronium bromide in children and adolescents, an adverse reaction was seen with an increased heart rate in up to 1 in 10 people.
How to store Rocuronium Fresenius Kabi
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 label and carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Storage outside the refrigerator:
Rocuronium Fresenius Kabi can also be stored outside the refrigerator at temperatures up to 30 ° C for a maximum of 12 weeks, after which time the vial should be destroyed. The product must not be stored in the refrigerator again after being stored without refrigeration. The storage period should not exceed the shelf life.
The product should be used immediately after opening the vial.
After dilution: Chemical and physical in-use stability using a 5 mg/ml and 0.1 mg/ml solution (diluted with sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solution for injection ) has been shown for 24 hours at room temperature and at exposure to daylight in glass, polyethylene and PVC. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions before administration is the responsibility of the user and would normally not be longer than 24 hours at 2-8 ° C unless dilution has taken place under controlled and validated aseptic conditions.
Do not use this medicine if you notice that the solution is not clear and free of particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
The active substance is rocuronium bromide.
Each ml contains 10 mg of rocuronium bromide.
Each 2.5 ml vial contains 25 mg of rocuronium bromide.
Each 5 ml vial contains 50 mg of rocuronium bromide.
Each 10 ml vial contains 100 mg of rocuronium bromide.
The other ingredients are sodium acetate trihydrate, sodium chloride, 100% concentrated acetic acid, and water for injections.
What the medicine looks like and the contents of the pack
Rocuronium Fresenius Kabi is a clear, colorless to light brownish-yellow solution for injection or infusion.
Rocuronium Fresenius Kabi is supplied in packs of 5 or 10 vials of 2.5 ml, 5 ml, or 10 ml solution for injection.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Fresenius Kabi AB
751 74 Uppsala
Fresenius Kabi Austria GmbH