Roqueronius Kabi - instructions for use, dose, side effects, contraindications

Active substanceRokuronium bromideRokuronium bromide

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Dosage form: & nbspRAsterol for intravenous administration

Composition:

1 ml of the solution contains:

Active substance:
rocuronium bromide	10 mg
Excipients:
Sodium chloride	3.3 mg
Sodium acetate trihydrate	2.0 mg
Acetic acid is ice (for pH correction)	7.139-8.725 mg
Water for injections	up to 1.0 ml

Description:A clear, colorless or brownish-yellow solution.

Pharmacotherapeutic group:muscle relaxant, non-depolarizing of peripheral action

ATX: & nbsp

M.03.A.C Other quaternary ammonium compounds

M.03.A.C.09 Rokuronium bromide

Pharmacodynamics:

Roqueronius Cubie (rocuronium bromide) - nondepolarizing muscle relaxant, with a short (closer to average) duration of action, having all the pharmacological effects (curare-like) that are characteristic of this class of drugs. It competitively blocks nicotinic cholinergic receptors of motor endings. Antagonists of this effect are cholinostearase inhibitors, such as neostigmine methylsulfate, edrophonium chloride and pyridostigmine bromide.

ED₉₀ (the dose necessary to suppress 90% of the reflex movement of the thumb of the hand in response to stimulation of the ulnar nerve) with a balanced anesthesia is about 0.3 mg / kg body weight.

Within 60 s after intravenous administration of rocuronium bromide at a dose of 0.6 mg / kg body weight (2 x ED₉₀ with a balanced anesthesia), adequate conditions for intubation are created in almost all patients. In 80% of cases they are the best. During 2 minutes develops a common myology, which allows for any intervention. The duration of the clinical effect of the drug (before spontaneous recovery of the degree of muscle contractions to 25% of the reference level) after the administration of this dose is 30-40 minutes. The total duration of action (time to restore the degree of muscle contractions to 90% of the reference level) is 50 minutes. The average time of spontaneous recovery of the degree of muscle contractions from 25% to 75% of the reference level (recovery index) after the administration of rocuronium bromide in the form of a bolus 0,6 mg / kg body weight is 14 minutes.

When rocuronium bromide was administered in smaller doses 0.3-0.45 mg / kg (1-1.5 (ED₉₀)) the action begins slower and its duration decreases (13-26 minutes). After the administration of rocuronium bromide at a dose of 0.45 mg / kg body weight, adequate conditions for intubation are created within 90 seconds.

With rapid induction of anesthesia with propofol or fentanyl / thiopental sodium, adequate conditions for intubation after administration of rocuronium bromide in a dose 1,0 mg / kg are created within 60 seconds in 93% and 96% of patients, respectively. In 70% of cases they are the best. The duration of the clinical effect of this dose reaches 1 hour. By the specified date neuromuscular blockade can be safely eliminated.

After the administration of rocuronium bromide at a dose of 0.6 mg / kg, adequate conditions for intubation are created within 60 seconds in 81% and 75% of patients who are used to induce anesthesia propofol or fentanyl / thiopental sodium, respectively.

The use of rocuronium bromide in doses greater than 1.0 mg / kg of body weight does not lead to a significant improvement in the conditions for intubation, however, the duration of action is thereby increased. Doses over 4 x ED₉₀not studied.

When managing patients in intensive care units rocuronium bromide prescribe in a dose 0,6 mg / kg, and then in the form of continuous maintenance infusion at a rate of 0,2-0.5 mg / kg / h during the first hour, when the degree of muscle contractions is restored to 10% of the reference level or appears 1-2 response in the four-digit stimulation (TOF - train of the four stimulation). Doses titrated individually, in the future they must be reduced under constant supervision TOF. Duration of application - 7 days.

Such a dosing regimen leads to the development of adequate miorelaxation, however, there is a significant variability in the rate of infusion and an increase in the duration of the blockade.

Time to recovery TOF up to 0.7 is reliably independent of the total duration of administration of rocuronium bromide. After a continuous infusion for 20 hours or more, the median (range) of time between the appearance of a second response to TOF stimulation and recovery TOF ratio to 0.7 ranges from 0.9 to 12 hours in patients without multiple organ failure and 1.2-25.5 hours in patients with multiple organ failure.

In newborns and children, the average rate of onset of the dose is 0.6 mg / kg higher than in adults. The duration of the drug in children is less than in adults.

The duration of action of maintenance doses of rocuronium bromide 0.15 mg / kg may slightly increase in anesthesia with enflurane and isoflurane in the elderly and patients with liver or kidney disease (approximately 20 minutes) compared with that in patients without disturbance of liver and kidney function during intravenous anesthesia (approximately 13 minutes).

With the subsequent introduction of recommended maintenance doses cumulation effect (progressive increase in duration of action) is not noted.

When conducting cardiovascular operations, the most frequent changes observed in patients during the development of maximal blockade after administration 0,6-0.9 mg / kg body weight, are small and clinically insignificant increases in heart rate (by 9%) and an increase in mean BP (by 16%) in comparison with the control values.

Pharmacokinetics:

It binds to plasma proteins at 30%.

Penetrates through the placental barrier.

After a single injection of rocuronium bromide in the form of a bolus, the dependence of its concentration in the plasma on time was exponential and consisted of three phases. In healthy adults, the mean half-life (95% CI) is 73 (66-80) minutes, the apparent volume of distribution in the equilibrium state is 203 (193-214) ml / kg, and the clearance from the plasma is 3.7 (3.5-3.9) ml / kg / min .

Clearance from plasma in the elderly and patients with impaired renal function is somewhat reduced compared with that in younger people with normal renal function.

In patients with liver disease, the average half-life is increased by 30 minutes, and the average clearance from plasma is reduced by 1 ml / kg / min.

The volume of distribution in newborns (3-12 months) is higher than in older children (1-8 years) and adults.

In children aged 3-8 years, the clearance is higher, and the half-life is approximately 20 minutes shorter than in adults and children under 3 years of age.

With continuous infusion for 20 hours or more during mechanical ventilation, the average half-life and the average volume of distribution in the equilibrium state increase.

There is a high interindividual variability associated with the nature and extent of multiple organ failure and individual patient characteristics.

In patients with multiple organ failure, the mean half-life (±SD) was 2.5 (± 3.3) h, the volume of distribution in the equilibrium state was 1.5 (± 0.8) l / kg, the clearance from the plasma was 2.1 (± 0.8) ml / kg / min .

Rokuronium bromide is excreted in the urine and bile.

The degree of excretion in the urine reaches 40% within 12-24 hours, 47% is excreted with feces. Approximately 50% of the dose is excreted as rocuronium bromide. Metabolites in plasma are not revealed.

Indications:

It is used in adults and children from 1 month:

- during general anesthesia, for facilitating intubation of the trachea with standard and rapid sequential induction anesthesia;

- for muscle relaxation during surgical interventions.

In intensive care units (ICU) for short-term muscle relaxation (for example, to facilitate intubation).

Contraindications:

- Anaphylactic reactions to rocuronium or bromine in the anamnesis;

- Children's age is up to 1 month.

Carefully:

Precautions for use

Diseases of the liver and biliary tract and kidney failure

Because the rocuronium bromide is excreted in the urine and bile, it should be used cautiously in patients with serious diseases of the liver and biliary tract and / or renal insufficiency. In such patients an increase in the duration of action of rocuronium bromide in a dose of 0.6 mg / kg is observed.

Increasing the circulation time

Conditions accompanied by slowed circulation, such as cardiovascular diseases, advanced age and edematous syndrome, cause an increase in the volume of distribution, which can lead to a delayed onset of action.

Neuromuscular diseases.

Like other muscle relaxants, rocuronium bromide should be used with extreme caution in patients with neuromuscular diseases or after poliomyelitis, since in such cases the response to neuromuscular blockade may change significantly. The severity and direction of these changes vary widely.

In patients with myasthenia gravis or myasthenic syndrome (Eaton-Lambert syndrome) rocuronium bromide can cause a pronounced effect in low doses, so its dose should be selected individually.

Hypothermia

In surgical interventions under hypothermia, the neuromuscular blocking effect of rocuronium bromide is enhanced, and the duration of its action is increased.

Obesity

If the dose of rocuronium bromide, as well as other muscle relaxants, in obese patients is calculated on the basis of actual body weight,it is possible to increase the duration of its action and the delayed recovery of neuromuscular transmission. Therefore, the dose is calculated based on the ideal body weight.

Burns

In patients with burns, resistance to non-depolarizing muscle relaxants may develop. The dose is recommended to be selected individually taking into account the patient's response.

States that can enhance the action of rocuronium bromide

Hypokalemia (eg, after severe vomiting, diarrhea or diuretic therapy), hypermagnesia, hypocalcemia (after massive transfusions), hypoproteinemia, dehydration, acidosis, hypercapnia and cachexia.

If possible, it is necessary to achieve correction of severe electrolyte disorders, changes in blood pH and dehydration.

Pregnancy and lactation:

Experience with rocuronium bromide during pregnancy is limited.

Rokuronium bromide should be given to pregnant women only if absolutely necessary, if the doctor believes that the benefits of using it exceed the possible risk.

At cesarean section rocuronium bromide it is recommended to prescribe in a dose of 0.6 mg / kg, since a dose of 1.0 mg / kg in pregnant women has not been studied.

The use of rocuronium bromide at a dose of 0.6 mg / kg during caesarean section does not affect the Apgar index, the muscle tone of the newborn and the adaptation of the function of the cardiovascular and respiratory system.

Magnesium salts, which are used to treat toxicosis in pregnant women, enhance neuromuscular blockade and can inhibit the recovery of neuromuscular transmission after the use of muscle relaxants. Accordingly, in such cases, the dose of rocuronium bromide should be lowered and titrated, taking into account the degree of muscle contraction. Rokuronium bromide Limitedly penetrates the placenta, which does not lead to unwanted reactions in newborns.

Experiments with rocuronium bromide in breast-feeding women no. Other drugs in this class are excreted in small amounts with breast milk and absorbed from a newborn breast-fed.

The decision on whether to stop breastfeeding should be taken in consideration of the importance of breastfeeding and the potential risk to the child.

Dosing and Administration:

Intravenously in the form of a bolus or continuous infusion.

The dose of rocuronium bromide, as well as other muscle relaxants, should be selected individually.

When choosing a dose, one should take into account the method of general anesthesia and the expected expected duration of the operation, the method of sedation and the estimated duration of artificial ventilation, the possibility of interaction with other medications and the patient's condition. To evaluate neuromuscular blockade and restore neuromuscular transmission, it is recommended to use instrumental methods of control.

Means for inhalation anesthesia enhance the miorelaksiruyuschee action of rocuronium bromide. This effect is of clinical importance during inhalation anesthesia, when a certain concentration of volatile substances is reached in the tissues. Accordingly, with prolonged inhalation anesthesia (more than 1 hour), lower maintenance doses of rocuronium bromide should be administered at longer intervals or the rate of infusion of the drug should be reduced.

Below are general recommendations on the dosage regimen of rocuronium bromide for tracheal intubation and muscle relaxation during short and long-term surgical interventions and in intensive care units.

Rokuronium bromide is intended for single use only.

Surgical interventions

Intubation of the trachea:

The standard dose of rocuronium bromide in normal anesthesia is 0.6 mg / kg body weight. This dose provides adequate conditions for intubation for 60 seconds in almost all patients.

With rapid sequential induction of anesthesia, the use of rocuronium bromide at a dose of 1.0 mg / kg body weight is recommended.

After applying this dose, adequate conditions for intubation are also created within 60 s in practically all patients. If with rapid sequential induction of anesthesia rocuronium bromide appointed at a dose of 0.6 mg / kg, then intubation should be carried out 90 seconds after the administration of the drug.

Maintenance doses:

The recommended maintenance dose of rocuronium bromide is 0.15 mg / kg body weight. With prolonged inhalation anesthesia, it should be reduced to 0.075-0.1 mg / kg body weight. The maintenance dose is best administered at the time when the degree of muscle contraction is restored to 25% of the control level or when there are 2-3 responses when monitoring in the four-digit stimulation modeTOF).

Continuous infusion:

Drip introduction of rocuronium bromide is recommended to begin with a loading dose of 0.6 mg / kg body weight.

When the neuromuscular blockade begins to recover, begin a continuous infusion of the drug.

The infusion rate is selected so as to maintain the degree of muscle contraction at 10% of the reference value or support 1-2 responses when monitoring in the mode TOF. With intravenous anesthesia in adult patients, the infusion rate necessary to maintain neuromuscular blockade at this level is 0.3-0.6 mg / kg / h.

With inhalation anesthesia, the infusion rate is 0.3-0.4 mg / kg / h.

It is necessary to constantly monitor the degree of neuromuscular blockade, since the necessary infusion rate differs in different patients and depends on the method of anesthesia.

Dosage regimen in children:

In children from 1 month, the recommended dose of rocuronium bromide during intubation during inhalation anesthesia and maintenance doses are similar to those in adults and are 0.3-0.6 mg / kg / h, and with inhalation anesthesia 0.3-0.4 mg / kg / h.

The rate of continuous infusion in adolescents is the same as in adults, but children may need a higher infusion rate.

Infants in infants start at the same rate as adults.In the future, the infusion rate is selected to maintain the degree of muscle contraction at 10% of the reference value or to maintain 1-2 responses when monitoring in the four-shot stimulation modeTOF).

The experience with rocuronium bromide in children with rapid sequential induction of anesthesia is limited. Concerning rocuronium bromide It is not recommended to use in children to facilitate intubation of the trachea with rapid introduction into anesthesia.

Data on the use of rocuronium bromide in newborns under the age of 1 month is not enough.

Dosage regimen in the elderly and patients with diseases of the liver, biliary tract and / or renal failure:

The standard intubation dose of rocuronium bromide for inhalation anesthesia in the elderly and patients with liver, biliary tract and / or renal failure is 0.6 mg / kg body weight. With fast sequential induction of anesthesia in patients who prolong the duration of the drug, the dose can also be 0.6 mg / kg, but adequate conditions for intubation can be created only 90 seconds after the administration of rocuronium bromide.

Regardless of the method of general anesthesia, the recommended maintenance dose of rocuronium bromide is 0.075-0.1 mg / kg, and the infusion rate is 0.3-0.4 mg / kg / h.

Dosing regimen in obese patients:

In patients with obesity (body weight of 30% or more exceeds ideal), it is necessary to reduce the dose taking into account the mass without adipose tissue.

Intensive therapy

Intubation of the trachea

When intubation of the trachea rocuronium bromide apply in the same doses as in surgical interventions.

Dosage while maintaining artificial ventilation:

It is recommended to start with a dose of 0.6 mg / kg of body weight, while restoring neuromuscular conductivity to 10% or receiving 1-2 responses with stimulation in the regime TOF begin to be administered intravenously in the form of a bolus or continuous infusion. Doses of rocuronium bromide should be selected individually. The recommended rate of administration in adult patients is 0.3-0.6 mg / kg / h for the first hour, after which, for 6-12 hours, the rate of administration should be reduced, according to the patient's individual response.

Roqueronium Cabi contains less than 1 mmol sodium (23 mg) in a single dose, i.e. insignificant amount of sodium.

Side effects:

By frequency, unwanted effects are divided into the following categories:

Very Frequent	≥1/10
Frequent	≥1/100-<1/10
Infrequent	≥ 1/1 000-<1/100
Rare	≥ 1/10 000-< 1/1 000
Very rare	< 1/10 000
Unknown	Can not be assessed based on available data

The main undesirable effects are pain / reaction at the injection site, changes in vital signs and a prolonged neuromuscular blockade.

Immune system disorders

Very rare:

- Anaphylactic reaction, for example, anaphylactic shock

- Anaphylactoid reactions *

- Hypersensitivity

Disturbances from the nervous system

Very rare:

- Paralyzes

Disorders from the cardiovascular system

Very rare:

- Tachycardia

- Reduction of blood pressure

- Collapse and shock

Disturbances from the respiratory system

Very rare:

- Bronchospasm

Frequency unknown:

- Apnea

- Respiratory failure

Disturbances from the skin

Very rare:

- Rash, erythematous rash

- Angioedema

- Hives

- Itching

- Exanthema

Disorders from the musculoskeletal system

Frequency unknown:

- weakness of skeletal muscles steroid myopathy *

Local Reactions

Very Frequent:

- Pain / reaction at the injection site *

Violations from laboratory blood indicators

Very rare:

- Increase in histamine content *

Injury, poisoning and complications of procedures

Very rare:

- Prolonged neuromuscular blockade *

* Additional information about adverse reactions:

Anaphylactic reactions

Severe anaphylactic reactions caused by muscle relaxants, in some cases, resulted in death.

Given the possible severity of such reactions, it is always necessary to take into account the risk of their development and take appropriate precautions.

Reactions at the site of administration

With rapid introduction to anesthesia, pain was observed at the injection site, especially in those cases when the patient still did not completely lose consciousness, and for the induction of anesthesia, propofol. In clinical trials, pain at the injection site was noted in 16% of patients who underwent rapid induction of anesthesia with propofol and less than 0.5% patients, the who for this purpose used fentanyl and thiopental sodium.

Increase of histamine content

Miorelaxants can cause local and systemic histamine release, so when using these drugs, the possibility of itching and the development of an erythematous reaction at the site of injection and / or generalized anaphylactoid reactions,such as bronchospasm and changes in the cardiovascular system (arterial hypotension and bradycardia).

In patients who received rocuronium bromide, rash, exanthema, urticaria, bronchospasm and arterial hypotension were very rare.

In clinical studies, after a rapid introduction of rocuronium bromide in the form of a bolus of 0.3-0.9 mg / kg body weight, a slight increase in plasma histamine level was noted.

Prolonged neuromuscular blockade

The most common side effect of the entire class of nondepolarizing muscle relaxants is an undesirable increase in the duration of the action, which varies from the weakness of skeletal muscles to the pronounced and prolonged paralysis that leads to the development of respiratory failure and apnea.

Overdose:

In case of an overdose and prolonged neuromuscular blockade, it is necessary to continue lung ventilation and sedation. When spontaneous recovery of neuromuscular transmission begins, an acetylcholinesterase inhibitor (for example, neostigmine, eudrophonia, pyridostigmine) should be given in an adequate dose.

If the administration of an acetylcholinesterase inhibitor does not lead to the elimination of the effect of rocuronium bromide,Continue mechanical ventilation until spontaneous breathing is restored. Repeated administration of an acetylcholinesterase inhibitor can be dangerous.

Interaction:

The following drugs influenced the extent and / or duration of action of nondepolarizing muscle relaxants:

Enhance the effect:

- Inhalational anesthetics: halothane, ether diethyl, enflurane, isoflurane, methoxyflurane, cyclopropane;

- Non-induction anesthetics: high doses of thiopental sodium, methohexital, ketamine, fentanyl, sodium oxybutyrate, etomidate and propofol;

- Other nondepolarizing muscle relaxants;

- Previous use of suxamethonium;

- Long-term treatment with corticosteroids and rocuronium bromide in intensive care units (ICU) may lead to an increase in the duration of neuromuscular blockade or myopathy;

- Preparations of other groups: antibiotics (aminoglycosides, lincosamides (lincomycin and clindamycin), polypeptide antibiotics, acylaminopenicillins, tetracyclines), high doses of metronidazole, diuretics, thiamine, monoamine oxidase inhibitors, quinidine, quinine, Protamine sulfate, adrenoblockers, magnesium salts, blockers of "slow" calcium channels, lithium salts and local anesthetics (lidocaine intravenous, epidural administration of bupivacaine).

Weakening effect:

- Neostigmine, eudrophonia, pyridostigmine, aminopyridine derivatives;

- Previous therapy with corticosteroids, phenytoin or carbamazepine;

- Norepinephrine, azathioprine (only a transient and limited effect), theophylline, calcium chloride, potassium chloride;

- HIV protease inhibitors.

Variable effect:

The use of other non-depolarizing muscle relaxants in combination with rocuronium bromide may lead to a weakening or strengthening of neuromuscular blockade, depending on the order of their use and the type of muscle relaxant.

The use of suxamethonium prior to the administration of rocuronium bromide may result in the enhancement or suppression of the miorelaxing effect of rocuronium bromide.

Effect of rocuronium bromide on the effects of other drugs:

Rokuronium bromide can accelerate the onset of action of lidocaine.

There was a recurrence on the background of postoperative use of aminoglycosides, lincosamides, polypeptides and acylaminopenicillins, quinidine, quinine and magnesium salts.

Pharmaceutical interaction

Incompatibility

The physical incompatibility of rocuronium bromide with solutions containing the following medicinal products has been established: amphotericin B, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, metohexital, methylprednisolone, prednisolone sodium succinate, sodium thiopental, trimethoprim and vancomycin.

Compatibility when mixed with other medicinal products

Rokuronium bromide in nominal concentrations of 0.5 mg / ml and 2.0 mg / ml is compatible with 0.9% sodium chloride solution, 5% dextrose in a 0.9% solution of sodium chloride, water for injection, Ringer's solution. The introduction should be started immediately after mixing and finished within 24 hours. Unused solutions should be disposed of.

Rokuronium bromide can be administered via the intravenous infusion system together with solutions of the following preparations for intravenous administration: epinephrine, alcuronium chloride, alfentanil, aminophylline, atracurium bezylate, atropine, ceftazidime, cefuroxime, cimetidine, clemastine,clindamycin, klometazola, clonazepam, clonidine, sodium danaparoid, dobutamine, dopamine, droperidol, ephedrine, ergotamine, esmolol, etomidate, fentanyl, flucytosine, gallamine triethiodide, gentamicin, 40% dextrose, glycopyrronium bromide, heparin, isoprenaline, ketamine, labetalol, lidocaine, 20% mannitol, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, morphine, nifedipine, nimodipine, nitroglycerin, norepinephrine, oxytocin, pancuronium bromide, pethidine, gipecuronium bromide, potassium chloride, n rometazine, propanolol, ranitidine, salbutomol, sodium hydrogen carbonate, nitroprusside, sufentanil, suxamethonium, vecuronium bromide, verapamil, and also with the preparation of the geloplasmic balance.

Special instructions:

Roqueronium bromide should be administered by physicians with experience in the use of muscle relaxants. It is necessary to have ready means for intubation of the trachea and artificial ventilation of the lungs.

Rokuronium bromide causes paralysis of the respiratory muscles, so when using it, artificial ventilation should be performed until self-breathing is restored.

As with the use of other muscle relaxants, it is important to foresee possible difficulties in intubation, especially with rapid sequential induction of anesthesia.

After the introduction of rocuronium bromide, as well as other muscle relaxants, there is a residual curarization. To avoid complications associated with residual curarization, it is recommended to stop intubation only after adequate restoration of neuromuscular transmission.

Other factors that can cause residual curarization after extubation in the postoperative period (for example, interaction with other drugs or the patient's condition) should also be considered. In this situation, it is necessary to discuss the possibility of using drugs that restore neuromuscular transmission, especially in those cases when the probability of residual curation is increased.

Before transporting the patient after leaving the anesthesia, you need to make sure that spontaneous, deep and regular breathing has recovered.

After the administration of muscle relaxants, anaphylactic reactions may develop. In this regard, it is necessary to always take precautions,especially if anaphylactic reactions occurred earlier with the introduction of other drugs of this group, given the possibility of cross reactivity.

Rokuronium bromide in a dose of more than 0.9 mg / kg can cause an increase in the heart rate. This effect can level the bradycardia, which develops under the influence of funds for anesthesia or stimulation of the vagus nerve.

After prolonged use of muscle relaxants in intensive care units, development of paralysis and / or weakness of skeletal muscles was noted. To avoid possible lengthening of neuromuscular blockade and / or overdose, with the use of muscle relaxants it is strongly recommended to control neuromuscular transmission. In addition, it is necessary to ensure adequate analgesia and sedation.

Dose of muscle relaxants should be selected individually under the supervision of experienced doctors on the basis of monitoring of neuromuscular transmission.

Rokuronium bromide is always used in combination with other medicines.

Given the possibility of developing malignant hyperthermia during anesthesia, even in the absence of known triggers, doctors should know the early signs of its manifestation, methods of diagnosis and treatment.

With the long-term use of nondepolarizing muscle relaxants and corticosteroids, the development of myopathy has been observed, so combination therapy should be administered as soon as possible.

Rokuronium bromide can be administered only after complete restoration of the neuromuscular blockade caused by suxamethonium.

Instructions for preparation and introduction

- The solution should be administered immediately after opening the vial.

- Before administration, the solution should be inspected. It is possible to introduce only a transparent solution that does not contain mechanical inclusions.

- The compatibility of rocuronium bromide with 0.9% sodium chloride solution and 5% solution of dextrose for intravenous administration.

After dilution, a solution of 5 mg / ml and 0, 1 mg / ml (diluted with 0.9% solution sodium chloride or 5% dextrose solution) is chemically and physically stable for 24 hours at room temperature in glass bottles and bags of polyethylene or polyvinyl chloride.

- If rocuronium bromide and other medications are administered through a single infusion system, it must be rinsed (eg, 0.9% solution of sodium chloride) between the administration of drugs. This is necessary in cases where rocuronium bromide and other drugs are incompatible, or their compatibility is not established.

- Remains of mortar and other wastes should be disposed of in accordance with applicable regulations.

If the solution is prepared under aseptic conditions, it can be stored for no more than 24 hours at a temperature of 2 to 8 ° C.

If necessary, specify special precautions for the destruction of unused medications

The unused solution must be destroyed in accordance with the current requirements for the disposal of drugs taken in this hospital.

Effect on the ability to drive transp. cf. and fur:

Rokuronium bromide has a pronounced effect on the ability to drive and use sophisticated technology. In the first 24 hours after complete recovery of neuromuscular blockade caused by rocuronium bromide, it is not recommended to drive and complex mechanisms.

Form release / dosage:Solution for intravenous administration, 10 mg / ml.

Packaging:

By 5 ml or 10 ml in bottles of colorless neutral glass of 1 class (Hebrew Pharm.), Sealed with rubber chlorobutyl plugs type 1 (Hebrew Pharm.) And crimped with aluminum caps with a plastic lid.

For 5 or 10 bottles together with the instruction for use are placed in a cardboard box (for hospitals).

Storage conditions:

Store at a temperature of 2 to 8 ° C.

Keep out of the reach of children.

Storage is allowed at temperatures up to 30 ° C for 12 weeks, after which the drug can not be used.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:PL-000703

Date of registration:28.09.2011

The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany

Manufacturer: & nbsp

FRESENIUS KABI AUSTRIA, GmbH Austria

HAMELN PHARMACEUTICALS, GmbH Germany

Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany

Information update date: & nbsp04.01.2017

Illustrated instructions

Instructions

Roqueronius Kabi (Rocuronium Kabi)