SUMMARY OF PRODUCT CHARACTIERISTICS OF THE MEDICINAL PRODUCT

1. NAME OF THE MEDICINAL PRODUCT

Rocuronium bromide Kabi 10 mg/ml Solution for injection / infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of the solution for injection / solution for infusion contains 10 mg of rocuronium bromide.
Each vial containing 2.5 ml contains 25 mg of rocuronium bromide.
Each vial containing 5 ml contains 50 mg of rocuronium bromide.
Each vial containing 10 ml contains 100 mg of rocuronium bromide.

For the complete list of other components please refer to Section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection /Solution for infusion

Clear, colorless to pale brownish-yellow solution.

pH-value of the solution: 3.8 to 4.2
Osmolality: 270 – 310 mOsmol/kg.

4. CLINICAL PARTICULARS

4.1 Areas of application

Rocuronium bromide Kabi is indicated in the case of adults and children (mature new born to
adolescents (0 to < 18 years)) as adjuvant in the treatment of general anaesthesia for facilitating
tracheal intubation during routine induction of lines and for relaxation of the skeletal musculature
during operations. In the case of adults, Rocuronium bromide Kabi is also indicated for easing
tracheal intubation during a rapid sequence induction and as adjuvant in intensive care units (e.g.
to make intubation easier), for short term use.

4.2 Posology and method of administration

Rocuronium bromide should be administered only by qualified professionals who are well versed
with the use of neuromuscular blockers. The equipment that is necessary for an endotracheal
intubation and artificial respiration and the corresponding staff must be available for immediate
induction.

As with other neuromuscular blockers, the dosage of rocuronium bromide must be customized for the
individual patient in question. The type of anesthesia, the expected duration of the operation, the type
of sedation and the expected duration of artificial ventilation, the possible drug interactions with other
pharmaceutical drugs that are used at the same time and the condition of the patient should be taken
into consideration while determining the dose. The use of a suitable neuromuscular monitoring system
for evaluating the neuromuscular blockade and the recovery time is recommended.
Inhalation anesthetics intensify the neuromuscular blockade action of rocuronium bromide. During
the course of an anesthesia, this intensification becomes clinically relevant, if inhalation anesthetics

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body weight, in accordance with the applicable clearance (l/h/kg). The volume of distribution (l/kg)
and the elimination half-life (h) decrease with age (in years). The pharmacokinetic parameters of
typical pediatric patients in every age group is summarized below as an example:

Estimated PK parameters of rocuronium bromide in typical pediatric patients under

Sevoflurane and nitrogen oxide (induction) and Isoflurane/nitrogen oxide (maintenance
anesthesia)
Age of the patient

PK Parameters New born Infant Small Children Adolescents

infant (0-27 (28 days to children (2-11 years) (12-17 years)
days) 2 months) (3-23
months)
CL (l/kg/h) 0.31 (0.07) 0.30 (0.08) 0.33 (0.10) 0.35 (0.09) 0.29 (0.14)

Volume of 0.42 (0.06) 0.31 (0.03) 0.23 (0.03) 0.18 (0.02) 0.18 (0.01)
distribution
(l/kg)
T1/2β (h) 1.1 (0.2) 0.9 (0.3) 0.8 (0.2) 0.7 (0.2) 0.8 (0.3)

5.3 Pre-clinical safety data

Based on the conventional studies on safety pharmacology, toxicity under repeated administration,
reproduction toxicity and genotoxicity, the non-clinical data do not give any indication of special
risks to humans.
Studies on carcinogenicity have not been carried out with rocuronium bromide.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for injection purposes

Acetic acid 99 % (for adjusting the pH-value)
Sodium chloride
Sodium acetate trihydrate

6.2 Incompatibilities

There are physical incompatibilities for rocuronium bromide if it is added to solutions with the
following active ingredients: Amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin,
dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone
sodium succinate, insulin, intralipid, methohexital, methyl prednisolone, prednisolone sodium
succinate, thiopental, trimethoprim and vancomycin.

The medical product should not be mixed with other pharmaceutical drugs except with
those listed under Section 6.6.

6.3 Shelf life

Unopened vial: 3 years.

Opened vial: The drug should be used immediately after opening the vial.

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After dilution:
The chemical and physical stability of a preparation of 5.0 mg/ml and 0.1 mg/ml (diluted with
sodium chloride 9 mg/ml (0.9 %) and glucose 50 mg/ml (5 %) solution for infusion) that is ready
for use has been proven for 24 hours at room temperature, under ambient light, in glass, PE and
PVC containers.
From the microbiological point of view, the ready to use preparation should be used immediately.
If the ready to use preparation cannot be used immediately, the user shall be responsible for the
duration and the conditions of storage. If the t ready for use preparation was not carried out under
controlled and validated aseptic conditions, this preparation should not be stored for more than 24
hours at temperatures between 2 °C and 8 °C.

6.4 Special precautions for storage

Store in the refrigerator (2 °C - 8 °C).

Storage outside the refrigerator:

Rocuronium bromide Kabi can be stored for a maximum of 12 weeks at temperatures of up to 30 °C; after
that it should be discarded. After removal from the refrigerator, the drug should not be put back into the
refrigerator again. The storage time should not exceed the shelf life.

Storage conditions of the medicinal product after dilution: please refer to Section 6.3.

6.5 Nature and contents of the container

Colorless vials made of glass (Type I) with chlorobutyl-rubber stoppers and

aluminum cap.
Contents of the vial: 2.5 ml, 5 ml or 10 ml.

Packaging size
Packages with 5 and 10 vials of 2.5 ml each.
Packages with 5 and 10 vials of 5 ml each.
Packages with 5 and 10 vials of 10 ml each.

All packaging sizes may not be released to the market.

6.6 Special precautions for disposal and other notes on handling

Unused solution should be discarded.

The solution should be evaluated visually before use. Only clear solutions that are free from
particles should be used.

It has been shown that Rocuronium bromide Kabi is compatible with the following solutions:
Sodium chloride 9 mg/ml (0.9 %) and Glucose 50 mg/ml (5 %) infusion solution.

If rocuronium bromide is administered through the same infusion line as the one used for other
drugs, it is important to ensure that this infusion line is rinsed adequately between the
administration of rocuronium bromide and drugs for which incompatibility with rocuronium
bromide has been established, or for which compatibility with rocuronium bromide has not been
proven (e. g. with sodium chloride 9 mg/ml (0.9 %) solution for infusion).

Unused drug or waste material should be disposed of in accordance with the

national requirements.

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