Bridion

Bridion

sugammadex

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Sugammadex Na.
Description
Each mL of solution for injection also contains the following excipients: Sodium 9.7 mg, hydrochloric acid 3.7% and/or sodium hydroxide (to adjust pH) and water for injections.
The pH is between 7 and 8, and osmolality is between 300 and 500 mOsmol/kg.
Action
Pharmacotherapeutic Group: All other therapeutic products. ATC Code: V03AB35.
Pharmacology: Mechanism of Action: Sugammadex is a modified γ-cyclodextrin, which is a selective relaxant binding agent. It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Pharmacodynamics: Sugammadex has been administered in doses ranging from 0.5-16 mg/kg in dose-response studies of rocuronium-induced blockade (rocuronium bromide 0.6, 0.9, 1 and 1.2 mg/kg with and without maintenance doses) and vecuronium-induced blockade (vecuronium bromide 0.1 mg/kg with or without maintenance doses) at different time points/depths of blockade. In these studies, a clear dose-response relationship was observed.
Clinical Efficacy and Safety: Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide.
Routine Reversal: Deep Neuromuscular Blockade: In a pivotal study, patients were randomly assigned to the rocuronium or vecuronium group. After the last dose of rocuronium or vecuronium, at 1-2 post-tetanic counts (PTCs), sugammadex 4 mg/kg or neostigmine 70 mcg/kg was administered in a randomised order. The time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio to 0.9 is shown in Table 1.

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Routine Reversal: Moderate Neuromuscular Blockade: In another pivotal study, patients were randomly assigned to the rocuronium or vecuronium group. After the last dose of rocuronium or vecuronium, at the reappearance of T2, sugammadex 2 mg/kg or neostigmine 50 mcg/kg was administered in a randomised order. The time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio to 0.9 is shown in Table 2.

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Reversal by sugammadex of the neuromuscular blockade induced by rocuronium was compared to the reversal by neostigmine of the neuromuscular blockade induced by cis-atracurium. At the reappearance of T2, a dose of sugammadex 2 mg/kg or neostigmine 50 mcg/kg was administered. Sugammadex provided faster reversal of neuromuscular blockade induced by rocuronium compared to neostigmine reversal of neuromuscular blockade induced by cis-atracurium. (See Table 3.)

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For Immediate Reversal: The time to recovery from succinylcholine-induced neuromuscular blockade (1 mg/kg) was compared with sugammadex-induced recovery (16 mg/kg, 3 min later) from rocuronium-induced neuromuscular blockade (1.2 mg/kg). (See Table 4.)

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In a pooled analysis, the following recovery times for sugammadex 16 mg/kg after rocuronium bromide 1.2 mg/kg were reported. (See Table 5.)

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Pharmacokinetics: The sugammadex pharmacokinetic (PK) parameters were calculated from the total sum of noncomplex-bound and complex-bound concentrations of sugammadex. Pharmacokinetic parameters as clearance and volume of distribution are assumed to be the same for noncomplex-bound and complex-bound sugammadex in anaesthetised subjects.
Distribution: The steady-state volume of distribution of sugammadex is approximately 11-14 L. Neither sugammadex nor the complex of sugammadex and rocuronium bind to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood. Sugammadex exhibits linear kinetics in the dosage range of 1-16 mg/kg when administered as an IV bolus dose.
Metabolism: In preclinical and clinical studies, no metabolites of sugammadex have been observed and only renal excretion of the unchanged product was observed as the route of elimination.
Elimination: The elimination half-life (t½) of sugammadex in adults is 1.8 hrs and plasma clearance is estimated to be 88 mL/min. A mass balance study demonstrated that >90% of the dose was excreted within 24 hrs. Ninety six percent (96%) of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex. Excretion via faeces or expired air was <0.02% of the dose. Administration of sugammadex to healthy volunteers resulted in increased renal elimination of rocuronium in complex.
Special Populations: Elderly and Renal Impairment: The PK parameters based on pharmacokinetic modeling in typical elderly and/or renally impaired patients are presented in Table 6.

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Paediatrics: Pharmacokinetics in paediatric patients (n=51) with ages ranging from 0-17 years were evaluated using population PK analysis. In patients <18 years, volume of distribution and clearance increase with increasing age. Variability of plasma concentrations of sugammadex in paediatric patients is comparable to the variability in adult patients. The PK parameters of 2 typical paediatric patients are summarised in Table 7.

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Gender: No gender differences were observed.
Race: In a study in healthy Japanese and Caucasian subjects, no clinically relevant differences in PK parameters were observed. Limited data does not indicate differences in PK parameters in Black or African Americans.
Body Weight: Population PK analysis of adult and elderly patients showed patients showed no clinically relevant relationship of clearance and volume of distribution with body weight.
Toxicology: Preclinical Safety Data: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity potential and toxicity to reproduction, local tolerance or compatibility with blood.
Sugammadex is rapidly cleared from most organs; however, some retention of compound occurs in bone and teeth of the rat. The most likely component involved in the reversible binding is hydroxy apatite, the inorganic matrix in these tissues. Preclinical studies in young adult and mature rats have shown that this retention does not adversely affect tooth colour or bone quality, structure, turnover and development. In juvenile rats, whitish discoloration was observed in the incisors and disturbance of enamel formation was observed upon repeated dosing; however, at exposure levels of 48-480 times the clinical exposure at 4 mg/kg.
Indications/Uses
Reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Paediatric Population: Sugammadex is only recommended for routine reversal of rocuronium-induced blockade in children and adolescents.
Dosage/Direction for Use
Sugammadex should only be administered by, or under the supervision of an anaesthetist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. As is normal post-anesthetic practice following neuromuscular blockade it is recommended to monitor the patient in the immediate postoperative period for untoward events including reoccurrence of blockade (see Precautions). When certain medicinal products that may cause displacement interactions are administered parenterally within a period of 6 hrs of sugammadex, the patient should be monitored for signs of reoccurrence of blockade (see Precautions and Interactions).
The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed.
The recommended dose does not depend on the anaesthetic regimen.
Sugammadex can be used to reverse different levels of rocuronium- or vecuronium-induced neuromuscular blockade.
Adults: Routine Reversal: A dose of sugammadex 4 mg/kg is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium- or vecuronium-induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 3 min (see Actions).
A dose of sugammadex 2 mg/kg is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium- or vecuronium-induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 2 min (see Pharmacology under Actions).
Using the recommended doses for routine reversal will result in a slightly faster median time to recovery of the T4/T1 ratio to 0.9 of rocuronium when compared to vecuronium-induced neuromuscular blockade (see Actions).
Immediate Reversal of Rocuronium-Induced Blockade: If there is a clinical need for immediate reversal following administration of rocuronium, a dose of sugammadex 16 mg/kg is recommended. When sugammadex 16 mg/kg is administered 3 min after a bolus dose of rocuronium bromide 1.2 mg/kg, a median time to recovery of the T4/T1 ratio to 0.9 of approximately 1.5 min can be expected (see Actions).
There is no data to recommend the use of sugammadex for immediate reversal following vecuronium-induced blockade.
Re-Administration of Sugammadex: In the exceptional situation of reoccurrence of blockade postoperatively (see Precautions) after an initial dose of sugammadex 2 or 4 mg/kg, a repeat dose of sugammadex 4 mg/kg is recommended. Following a 2nd dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
Re-Administration of Rocuronium or Vecuronium After Sugammadex: A waiting time of 24 hrs should be taken into account (see Precautions).
Additional Information on Special Population: Renal Impairment: For mild and moderate renal impairment [creatinine clearance (CrCl) ≥30 and <80 mL/min], the dose recommendations are the same as for adults.
The use of sugammadex in patients with severe renal impairment [including patients requiring dialysis (CrCl <30 mL/min)] is not recommended (see Precautions).
Elderly: After administration of sugammadex at reappearance of T2 following a rocuronium-induced blockade, the median time to recovery of the T4/T1 ratio to 0.9 in adults (18-64 years) was 2.2 min, in elderly adults (65-74 years), it was 2.6 min and in very elderly adults (≥75 years), it was 3.6 min. Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed (see Precautions).
Obese Patients: In obese patients, the dose of sugammadex should be based on actual body weight. The same dose recommendations as for adults should be followed.
Hepatic Impairment: For mild to moderate hepatic impairment, as sugammadex is mainly excreted renally, no dose adjustments are required. Studies in patients with hepatic impairment have not been conducted and therefore, patients with severe hepatic impairment should be treated with great caution (see Precautions).
Paediatric Population: The data for the paediatric population are limited (1 study only for reversal of rocuronium-induced blockade at reappearance of T2).
Children and Adolescents: For routine reversal of rocuronium-induced blockade at reappearance of T2 in children and adolescents (2-17 years), sugammadex 2 mg/kg is recommended. Other routine reversal situations have not been investigated and are therefore not recommended until further data become available.
Immediate reversal in children and adolescents has not been investigated and is therefore not recommended until further data become available.
Bridion 100 mg/mL may be diluted to 10 mg/mL to increase the accuracy of dosing in the paediatric population (see Cautions for Usage).
Term Newborn Infants and Infants: There is only limited experience with the use of sugammadex in infants (30 days to 2 years) and term newborn infants (<30 days) have not been studied. The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available.
Administration: Sugammadex should be administered IV as a single bolus injection. The bolus injection should be given rapidly, within 10 sec directly into a vein or into an existing IV line (see Cautions for Usage). Sugammadex has only been administered as a single bolus injection in clinical trials.
Overdosage
In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant undesirable effects. In a human tolerance study, sugammadex was administered in doses up to 96 mg/kg. No dose-related adverse events nor serious adverse events were reported.
Contraindications
Hypersensitivity to sugammadex or to any of the excipients of Bridion.
Special Precautions
Monitoring Respiratory Function During Recovery: Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular block. Even if recovery from neuromuscular blockade is complete, other medicinal products used in the peri- and postoperative period could depress respiratory function and therefore, ventilatory support might still be required.
Should neuromuscular blockade reoccur following extubation, adequate ventilation should be provided.
Effect on Hemostasis: In in vitro experiments, a pharmacodynamic interaction [activated partial thromboplastin time (aPTT) and prothrombin time (PT) prolongation] was noted with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran. In a study in volunteers, doses of sugammadex 4 and 16 mg/kg prolonged by 17-22% for the aPTT and 11-22% for PT. In all cases, this slight prolongation was of short duration (≤30 min). Based on the clinical database (n=1738), there was no clinically relevant effect of sugammadex alone or in combination with anticoagulants on the incidence of peri- or postoperative bleeding complications.
Considering the transient nature of the prolongation of a PTT and PT caused by sugammadex alone or on top of these anticoagulants, it is unlikely that sugammadex has an increased risk of bleeding. Since there is no information on the use of sugammadex in patients with known coagulopathies, coagulation parameters should be carefully monitored according to routine clinical practice.
Reoccurrence of Blockade: In clinical trials, reoccurrence of blockade was reported mainly when suboptimal doses (in dose finding studies) were administered. In order to prevent reoccurrence of neuromuscular blockade, the recommended doses for routine or immediate reversal (see Dosage & Administration) should be used.
Waiting Times for Re-Administration with Neuromuscular Blocking Agents After Reversal with Sugammadex: If re-administration of rocuronium or vecuronium is required, a waiting time of 24 hrs is recommended.
If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.
Renal Impairment: In patients with severe renal failure (CrCl <30 mL/min), the excretion of sugammadex or the sugammadex-rocuronium complex was delayed; however, in these patients, there were no signs of reoccurrence of neuromuscular blockade. Data from a limited number of renally impaired patients requiring dialysis indicate an inconsistent decrease of plasma levels of sugammadex by haemodialysis. The use of sugammadex in patients with severe renal impairment is not recommended.
Interactions due to the Lasting Effect of Rocuronium or Vecuronium: When medicinal products which potentiate neuromuscular blockade are used in the postoperative period, special attention should be paid to the possibility of reoccurrence of blockade. Refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade. In case reoccurrence of blockade is observed, the patient may require mechanical ventilation and re-administration of sugammadex (see Dosage & Administration).
Potential Interactions: Capturing Interactions: Due to the administration of sugammadex, certain medicinal products could become less effective due to a lowering of the (free) plasma concentrations (see Interactions: Hormonal Contraceptives).
If such a situation is observed, the clinician is advised to consider the re-administration of the medicinal product, the administration of a therapeutically equivalent medicinal product (preferably from a different chemical class) and/or nonpharmacological interventions as appropriate.
Displacement Interactions: Due to the administration of certain medicinal products after sugammadex, theoretically, rocuronium or vecuronium could be displaced from sugammadex. As a result, reoccurrence of blockade might be observed. In this situation the patient must be ventilated. Administration of the medicinal product which caused displacement should be stopped in case of an infusion. In situations when potential displacement interactions can be anticipated, patients should be carefully monitored for signs of reoccurrence of blockade (approximately up to 15 min) after parenteral administration of another medicinal product occurring within a period of 6 hrs after sugammadex administration. Displacement interactions are, at present, only expected for a few drugs substances (toremifene, flucloxacillin and fusidic acid). (See Interactions.)
Light Anaesthesia: When neuromuscular blockade was reversed intentionally in the middle of anaesthesia in clinical trials, signs of light anaesthesia were noted occasionally (movement, coughing, grimacing and suckling of the tracheal tube).
If neuromuscular blockade is reversed while anaesthesia is continued, additional doses of anaesthetic and/or opioid should be given as clinically indicated.
Hepatic Impairment: Sugammadex is not metabolised nor excreted by the liver; therefore, dedicated studies in patients with hepatic impairment have not been conducted. Patients with severe hepatic impairment should be treated with great caution.
Use in Intensive Care Unit (ICU): Sugammadex has not been investigated in patients receiving rocuronium or vecuronium in the ICU setting.
Use for Reversal of Neuromuscular Blocking Agents other than Rocuronium or Vecuronium: Sugammadex should not be used to reverse block induced by nonsteroidal neuromuscular blocking agents eg, succinylcholine or benzylisoquinolinium compounds.
Sugammadex should not be used for reversal of neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium, since there are no efficacy and safety data for these situations. Limited data are available for reversal of pancuronium-induced blockade, but it is advised not to use sugammadex in this situation.
Delayed Recovery: Conditions associated with prolonged circulation time eg, cardiovascular disease, old age (see Dosage & Administration) or oedematous state may be associated with longer recovery times.
Drug Hypersensitivity: Clinicians should be prepared for the possibility of drug hypersensitivity reactions (including anaphylactic reactions) and take the necessary precautions (see Adverse Reactions).
Patients on a Controlled Sodium Diet: Each mL solution contains sodium 9.7 mg. A dose of sodium 23 mg is considered essentially 'sodium-free'. If >2.4 mL solution needs to be administered, this should be taken into consideration by patients on a controlled sodium diet.
QTc Interval Prolongation: Two thorough QTc trials (N=146), both in conscious volunteers, demonstrated that sugammadex alone or in combination with rocuronium or vecuronium are not associated with QTc interval prolongation. The one-sided 95% upper confidence limits for the QTc difference to placebo were well below the 10 msec margin for each of the 12-13 evaluated timepoints in both studies.
In the clinical program, a few cases of QTc prolongation were reported (QTc >500 msec or QTc increases >60 msec) in clinical trials in which patients received sugammadex in combination with sevoflurane or propofol. During anaesthesia several medicinal products with the potential to prolong QTc (eg, sevoflurane) are administered. The routine precautions for treating arrhythmia should be taken into consideration.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed.
Use in pregnancy & lactation: For sugammadex, no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Caution should be exercised when administering sugammadex to pregnant women.
It is unknown whether sugammadex is excreted in human breast milk. Animal studies have shown excretion of sugammadex in breast milk. Oral absorption of cyclodextrins in general is low and no effects on the suckling child are anticipated following a single dose to the breastfeeding woman.
Sugammadex can be used during breastfeeding.
Use In Pregnancy & Lactation
For sugammadex, no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Caution should be exercised when administering sugammadex to pregnant women.
It is unknown whether sugammadex is excreted in human breast milk. Animal studies have shown excretion of sugammadex in breast milk. Oral absorption of cyclodextrins in general is low and no effects on the suckling child are anticipated following a single dose to the breastfeeding woman.
Sugammadex can be used during breastfeeding.
Adverse Reactions
The safety of sugammadex has been evaluated based on an integrated safety database of approximately 1700 patients and 120 volunteers. The most commonly reported adverse reaction, dysgeusia (metal or bitter taste), was mainly seen after doses of sugammadex ≥32 mg/kg.
Immune System Disorders: Uncommon (≥1/1000 to <1/100): Drug hypersensitivity reactions (see Precautions).
Injury, Poisoning and Procedural Complications: Common (≥1/100 to <1/10): Anaesthetic complication (see Precautions). Uncommon (≥1/1000 to <1/100): Unwanted awareness during anaesthesia.
Nervous System Disorders: Very Common (≥1/10) in Volunteers: Dysguesia.
Anaesthetic Complications: Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing or suckling on the endotracheal tube (see Precautions: Light Anaesthesia).
Awareness: In sugammadex-treated subjects, a few cases of awareness were reported. The relation to sugammadex is uncertain.
Reoccurrence of Blockade: In the database of pooled phase I-III studies with a placebo group, the incidence of reoccurrence of blockade as measured with neuromuscular monitoring was 2% after sugammadex and 0% in the placebo group. Virtually, all of these cases were from dose-finding studies in which a suboptimal dose (<2 mg/kg) was administered (see Precautions).
Drug Hypersensitivity Reactions: Hypersensitivity reactions have occurred in some patients and volunteers. In clinical trials, these reactions were reported uncommonly and for post-marketing reports, the frequency is unknown.
These reactions varied from isolated skin reactions to serious systemic reactions (ie, anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.
Symptoms associated with these reactions can include: Flushing, urticaria, erythematous rash, hypotension (severe), tachycardia and swelling of tongue and pharynx.
Additional Information on Special Populations: Pulmonary Patients: In 1 clinical trial in patients with a history of pulmonary complications, bronchospasm was reported as a possibly related adverse event in 2 patients and a causal relationship could not be fully excluded. As with all patients with a history of pulmonary complications, the physician should be aware of the possible occurrence of bronchospasm. Paediatric Population: A limited database suggests that the safety profile of sugammadex (up to 4 mg/kg) in paediatric patients was similar to that in adults.
Drug Interactions
No interaction studies have been conducted in adults with sugammadex and other medicinal products. The information in this section is based on binding affinity between sugammadex and other medicinal products, nonclinical experiments and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex. Based on in vitro data and taking into consideration pharmacokinetics and other relevant information, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following:
For toremifene, flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
For hormonal contraceptives, a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).
Interactions Potentially Affecting the Efficacy of Sugammadex (see also Precautions): Toremifene: For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur. The recovery of the T4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation.
IV Administration of Flucloxacillin and Fusidic Acid: IV administration of fusidic acid and high-dose flucloxacillin (infusion of ≥500 mg) may cause some displacement of rocuronium or vecuronium from sugammadex. The use of these medicinal products in the preoperative phase may give some delay in the recovery of the T4/T1 ratio to 0.9. The use of these medicinal products in the postoperative phase after routine reversal during the surveillance period of 6 hrs (see Precautions) should be avoided. If administration of flucloxacillin or fusidic acid within this time period cannot be avoided, ventilation should be closely observed, in particular during the first 15 min after dosing. For re-administration of sugammadex, see Dosage & Administration.
Interactions Potentially Affecting the Efficacy of Other Medicinal Products (see Precautions): Hormonal Contraceptives: The interaction between sugammadex 4 mg/kg and a progestogen was predicted to lead to a decrease in progestogen exposure (34% of AUC) similar to the decrease seen when a missed daily dose of an oral contraceptive is taken 12 hrs late, which might lead to a reduction in effectiveness. For estrogens, the effect is expected to be lower. Therefore, the administration of a bolus dose of sugammadex is considered to be equivalent to 1 missed daily dose of oral contraceptive steroids (either combined or progestogen only). If sugammadex is administered at the same day as an oral contraceptive is taken, reference is made to missed dose advice in the package leaflet of the oral contraceptive. In the case of non-oral hormonal contraceptives, the patient must use an additional nonhormonal contraceptive method for the next 7 days and refer to the advice in the package leaflet of the product.
Interference with Laboratory Tests: In general, sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay. Interference with this test is observed at sugammadex plasma concentrations of 100 mcg/mL.
Paediatric Population: No formal interaction studies have been performed. The previously mentioned interactions for adults and precautions should also be taken into account for the paediatric population.
Incompatibilities: Bridion must not be mixed with other medicinal products except those mentioned under Cautions for Usage. Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.
Caution For Usage
If Bridion is administered via the same infusion line that is also used for other medicinal products, it is important that the infusion line is adequately flushed [eg, with sodium chloride 9 mg/mL (0.9% solution)] between administration of Bridion and medicinal products for which incompatibility with Bridion has been demonstrated or for which compatibility with Bridion has not been established.
Sugammadex can be injected into the IV line of a running infusion with the following IV solutions: Sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%), Ringers lactate solution, Ringers solution, glucose 50 mg/mL (5%) in sodium chloride 9 mg/mL (0.9%).
For paediatric patients, Bridion can be diluted using sodium chloride 9 mg/mL (0.9%) to a concentration of 10 mg/mL (see Storage).
Any unused product or waste material should be disposed of in accordance with local requirements.
Storage
Store at or below 30°C. Do not freeze. Store in original package in order to protect from light.
The vials may be stored outside the carton for up to 5 days.
After first opening and dilution, chemical and physical in-use stability has been demonstrated for 48 hrs at 2-25°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 and would normally not be longer than 24 hrs at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Shelf-Life: 3 years.
ATC Classification
V03AB35 - sugammadex ; Belongs to the class of antidotes. Used to reverse neuromuscular blockade caused by rocuronium or vecuronium.
Presentation/Packing
Inj (vial) 100 mg/mL (clear, colourless to slightly yellow, soln for inj) x 1 mL x 1's, 2 mL x 10's, 5 mL x 10's.
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