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medicalmeds.eu Medicines Detoksitsiruyushchy means. Antidotes. Брайдан®

Брайдан®

Препарат Брайдан®. Merck Sharp & Dohme Corp. (Мерк Шарп и Доум Корп.) США


Producer: Merck Sharp & Dohme Corp. (Merck Sharp and Doum of the Building) USA

Code of automatic telephone exchange: V03AB35

Release form: Liquid dosage forms. Solution for injections.

Indications to use: Poisonings with medicines.


General characteristics. Structure:

Active ingredients: 108,8 mg of a sugammadeks of sodium that makes 100 mg of a sugammadeks.

Excipients: Acidum hydrochloricum - q.s. to pH 7.5, sodium hydroxide - q.s. to pH 7.5, water for injections.




Pharmacological properties:

Pharmacodynamics. The selection antidote of muscle relaxants rokuroniya of bromide and vekuroniya of bromide. Сугаммадекс represents the modified gamma cyclodextrin which is the connection selectively connecting a rokuroniya bromide and a vekuroniya bromide. It creates with them a complex in a blood plasma that leads to decrease in concentration of the muscle relaxant contacting nicotinic receptors in a neuromuscular synapse. It leads to elimination of the neuromuscular blockade caused a rokuroniya by bromide or a vekuroniya bromide.

Accurate dependence of effect of a dose of a sugammadeks who was entered into various spans and with various depth of the block of neuromuscular conductivity was observed. Сугаммадекс entered in doses from 0.5 to 16 mg/kg as after single introduction a bromide rokuroniya in doses of 0.6, 0.9, 1 and 1.2 mg/kg, or after introduction a bromide vekuroniya in a dose of 0.1 mg/kg, and after introduction of maintenance doses of these muscle relaxants.

Сугаммадекс it is possible to apply in various spans after introduction a rokuroniya of bromide or a vekuroniya of bromide.

Renal failure. In two open clinical trials comparison of efficiency and safety of use of a sugammadeks for patients with a renal failure of heavy degree or without it, exposed to surgical intervention was carried out. In one of researches сугаммадекс it was entered for elimination of the blockade caused a rokuroniya by bromide in the presence of 1-2 post-tetanic answers (4 mg/kg; n =))); in other research сугаммадекс entered at emergence of the second answer in the mode of four-digit stimulation (T2) (2 mg/kg; n=30). Recovery of neuromuscular conductivity after blockade was insignificant longer at patients with a renal failure of heavy degree in comparison with patients without renal failure. Cases of residual neuromuscular blockade or its resuming at patients with a renal failure of heavy degree in these researches were not observed.

Influence on QTc interval. In three clinical trials of the sugammadeks applied in the monotherapy mode, or in a combination with a rokuroniya bromide or a vekuroniya bromide or in a combination with propofoly or sevoflurany, clinically significant increase in QT/QTc of an interval was not observed.

Pharmacokinetics. Pharmacokinetic parameters of a sugammadeks are calculated proceeding from summing of concentration of a free sugammadeks and a sugammadeks as a part of a complex a sugammadeks-muscle relaxant. Pharmacokinetic parameters, such as clearance and Vd, are considered identical to the sugammadeks which is out of a complex, and the sugammadeks which is in structure of a complex with a muscle relaxant.

Later in/in introductions to adult patients сугаммадекс shows the following pharmacokinetic properties: a bystry phase of distribution with the semi-distribution period - 2.9 min.; a slow phase of distribution with the semi-distribution period — 27 min.; T1/2 is 1.8 h, Vss - 11-14 l. Clearance of drug - 88 ml/min.

Distribution. Observed Vd of a sugammadeks in an equilibrium state at adult patients with normal function of kidneys makes 11-14 l (based on the standard pharmacokinetic analysis without division into kompartment). сугаммадекс, a complex a sugammadeks-rokuroniya bromide do not contact proteins of a blood plasma or erythrocytes. At bolyusny introduction of a sugammadeks in doses from 1 to 16 mg/kg its pharmacokinetics has linear character.

Metabolism. Сугаммадекс it is removed by kidneys in not changed look. Currently metabolites of a sugammadeks are not found.

Removal. At adult patients with normal renal function which carried out anesthesia T1/2 of a sugammadeks makes about 2,5 h, and the expected clearance of plasma - 75 ml/min. (based on the pharmacokinetic analysis with use of trekhkompartmentny model). More than 90% of a dose are removed during 24 h 96% of a dose removed with urine of which 95% make not changed сугаммадекс. Less than 0.02% of a sugammadeks are removed with a stake and with expired air.

Pharmacokinetics in special clinical cases. Pharmacokinetic parameters at patients of advanced age with various degree of a renal failure which was measured by means of definition of KK were estimated when using the population pharmacokinetic analysis.

Results of two pharmacokinetic researches to whom comparison of patients with a renal failure of heavy degree and patients with normal function of kidneys was carried out showed that concentration of a sugammadeks in plasma were similar within at least first 20 min. after administration of drug and afterwards went down in control group. The general duration of action of a sugammadeks at patients with a renal failure was increased that was expressed in its almost 15-fold lengthening. At some patients the minimum concentration of a sugammadeks decided on a heavy renal failure in plasma even in 1 month after administration of drug.

Table. The pharmacokinetic parameters of a sugammadeks calculated depending on age and a condition of function of kidneys and with use of trekhkompartmentny model.

s017.radikal.ru/i405/1602/c7/2ee36dffd3ef.png

 Average values and coefficient of variation (%) are presented.


Indications to use:

— elimination of the neuromuscular blockade caused a rokuroniya by bromide or a vekuroniya bromide;

— elimination of the neuromuscular blockade caused a rokuroniya by bromide in children of 2 years and teenagers in standard clinical situations.


Route of administration and doses:

Сугаммадекс it has to be entered only by the anesthesiologist or under his management. It is recommended to apply the corresponding method of monitoring to observation of extent of neuromuscular blockade and recovery of neuromuscular conductivity. According to the standard practice, it is also recommended to carry out monitoring of neuromuscular conductivity in the postoperative period regarding the undesirable phenomena, including resuming of neuromuscular blockade. If during 6 h after introduction of a sugammadeks parenterally appoint drugs which can lead to development of medicinal interaction as replacement, it is necessary to carry out monitoring of neuromuscular conductivity regarding emergence of signs of resuming of neuromuscular blockade.

The recommended dose of a sugammadeks depends on extent of neuromuscular blockade which needs to be eliminated.

The recommended dose does not depend on a type of anesthesia. Adults. Сугаммадекс apply to elimination of blockade of neuromuscular conductivity of various depth caused a rokuroniya by bromide or a vekuroniya bromide.

Elimination of neuromuscular blockade in standard clinical situations (residual blockade of neuromuscular conductivity). Сугаммадекс in a dose of 4 mg/kg it is recommended to enter when recovery of neuromuscular conductivity reached the level of 1-2 post-tetanic reductions (in the mode of the post-tetanic account (PTS)) after the blockade caused a rokuroniya by bromide or a vekuroniya bromide. Average time to a complete recovery of neuromuscular conductivity (recovery of a ratio of amplitudes of the fourth and first answers in the mode of four-digit stimulation (T4/T1) to 0.9) makes about 3 min. Sugammadeks in a dose of 2 mg/kg is recommended to be entered when spontaneous recovery of neuromuscular conductivity after the blockade caused a rokuroniya by bromide or a vekuroniya bromide reached not less than 2 answers in the mode of four-digit stimulation (TOF). Average time before recovery of the relation of T4/T1 to 0.9 makes about 2 min.

At use of a sugammadeks in the recommended doses for recovery of neuromuscular conductivity in standard clinical situations more bystry recovery of the relation of T4/T1 to 0.9 happens in case neuromuscular blockade is caused a rokuroniya by bromide in comparison with a vekuroniya bromide.

The emergency elimination of the neuromuscular blockade caused a rokuroniya by bromide. At emergence of the necessity in immediate recovery of neuromuscular conductivity at the blockade caused a rokuroniya by bromide, the recommended dose of a sugammadeks makes 16 mg/kg.

At introduction of a sugammadeks in a dose of 16 mg/kg in 3 min. after introduction of a bolyusny dose of 1.2 mg/kg the bromide rokuroniya the average time of recovery of the relation of T4/T1 to 0.9 makes about 1.5 min.

Repeated introduction of a sugammadeks. In exclusive situations at a rekurarization in the postoperative period, after introduction of a sugammadeks in a dose of 2 mg/kg or 4 mg/kg, the recommended repeated dose of a sugammadeks makes 4 mg/kg. After introduction of a repeated dose of a sugammadeks it is necessary to carry out monitoring of neuromuscular conductivity until a complete recovery of neuromuscular function.

Use of drug for special groups of patients. At patients with an easy and moderate renal failure (KK of 30-80 ml/min.) drug should be used in the doses recommended for adult patients without renal failure. Use of a sugammadeks for patients with heavy renal failures, including patients who are on a program hemodialysis (KK <30 ml/min.) is not recommended. Results of researches of use at a renal failure of heavy degree were not reported by enough data on safety which would allow to recommend use of a sugammadeks for this group of patients.

At abnormal liver functions the recommended doses of drug remain same, as well as with adult patients as сугаммадекс it is removed mainly by kidneys. Because of insufficiency of data on use of a sugammadeks for patients with a liver failure of heavy degree and in cases when the liver failure is followed by the coagulopathy phenomena, it is recommended to apply сугаммадекс with extra care.

Patients of advanced age: after introduction of a sugammadeks in the presence of 2 answers in the stimulation TOF mode against the background of the blockade caused a rokuroniya by bromide, total time of recovery of neuromuscular conductivity (T4/T1 relation to 0.9) at adult patients (18-64 years) 2.2 min., at patients of advanced age (65-74 years) - 2.6 min. and at patients of senile age (75 years average and more) - 3.6 min. In spite of the fact that time of recovery of neuromuscular conductivity at patients of advanced age is slightly more, doses of a sugammadeks are recommended same, as for adult patients of a usual age group.

At patients with obesity calculation of a dose of a sugammadeks should be perfromed proceeding from the actual body weight. It is necessary to follow the recommended doses offered for adult patients.

Children. Data on use of a sugammadeks for children are limited. Administration of drug for elimination of the neuromuscular blockade caused a rokuroniya by bromide at emergence of 2 answers in the stimulation TOF mode is possible.

For elimination of the neuromuscular blockade caused a rokuroniya by bromide in daily practice at children and teenagers aged from 2 up to 17 years it is recommended to enter сугаммадекс in a dose 2 mg/kg (in the presence of 2 answers in the stimulation TOF mode).

Other situations of recovery of neuromuscular conductivity which are found in standard practice were not studied therefore in these cases it is not recommended to apply сугаммадекс before obtaining the subsequent data.

The emergency recovery of neuromuscular conductivity at introduction of a sugammadeks at children of 2 years and teenagers was not investigated and therefore in these situations use of drug is not recommended before obtaining the subsequent data.

Drug can be dissolved for increase in accuracy of dosing at children.

Rules of administration of drug. Сугаммадекс enter in/in struyno in the form of a single bolyusny injection during 10 sec. directly into a vein or into system for into introductions.

If сугаммадекс enter through uniform infusional system with other medicines, it is necessary to wash out carefully system (for example, 0.9% chloride sodium solution) between administration of the drug Braydan® and the drugs having with it incompatibility and also if compatibility is not established.

Сугаммадекс it is possible to enter into one system for in/in introductions together with the following infusion solutions: 0.9% (9 mg/ml) chloride sodium solution; 5% (50 mg/ml) dextrose solution; 0.45% (4.5 mg/ml) chloride sodium solution from 2.5% (25 mg/ml) dextrose solution; Ringer's solution with lactic acid; Ringer's solution; 5% (50 mg/ml) dextrose solution in 0.9% (9 mg/ml) chloride sodium solution. For use for children the drug Braydan® can be divorced by means of 0.9% (9 mg/ml) of chloride sodium solution to concentration of 10 mg/ml.


Features of use:

Use at pregnancy and feeding by a breast. It is not recommended to apply сугаммадекс at pregnancy in connection with insufficiency of data. Studying of allocation of a sugammadeks with milk at women in the period of a lactation was not carried out, but, proceeding from these preclinical trials, this probability is not excluded. Absorption of cyclodextrins through a mouth low also does not exert impact on the child after introduction of a bolyusny dose of a sugammadeks of the nursing mother. However it is necessary to apply сугаммадекс at women during breastfeeding with care.

Use at abnormal liver functions. It is contraindicated at a heavy liver failure.

Use at renal failures. It is contraindicated at a renal failure of heavy degree (KK <30 ml/min.).

Use for children. It is contraindicated at children's age up to 2 years.

Use for elderly patients. Patients of advanced age: after introduction of a sugammadeks in the presence of 2 answers in the stimulation TOF mode against the background of the blockade caused a rokuroniya by bromide, total time of recovery of neuromuscular conductivity (T4/T1 relation to 0.9) at adult patients (18-64 years) 2.2 min., at patients of advanced age (65-74 years) - 2.6 min. and at patients of senile age (75 years average and more) - 3.6 min. In spite of the fact that time of recovery of neuromuscular conductivity at patients of advanced age is slightly more, doses of a sugammadeks are recommended same, as for adult patients of a usual age group.

Special instructions. Monitoring of respiratory function during recovery of neuromuscular conductivity. It is necessary to carry out IVL to a complete recovery of adequate independent breath after elimination of neuromuscular blockade. Even if there was a complete recovery of neuromuscular conductivity, other medicines which were applied in peri-and the postoperative periods, can oppress respiratory function and therefore the prolonged IVL can be required.

If after extubation neuromuscular blockade repeatedly develops, it is necessary to provide adequate ventilation of the lungs in time.

Resuming of neuromuscular blockade. Repeated development of neuromuscular blockade was observed mainly in cases when suboptimal (insufficient) doses of drug were entered. For the purpose of the prevention of resuming of neuromuscular blockade doses below recommended should not be applied.

Periods through which it is possible to enter repeatedly muscle relaxants after recovery of neuromuscular conductivity by means of a sugammadeks

Repeated introduction a rokuroniya of bromide or a vekuroniya of bromide after use of a sugammadeks (to 4 mg/kg) is possible through the following periods:

s019.radikal.ru/i636/1602/27/edcd171c00a4.png

Based on pharmacokinetic model, the period through which it is possible to enter repeatedly 0.6 mg/kg a rokuroniya of bromide or 0.1 mg/kg a bromide vekuroniya after use of a sugammadeks to patients with easy or moderate degree of a renal failure has to make 24 h. If shorter period for resuming of neuromuscular blockade is required, the dose a rokuroniya of bromide has to make 1.2 mg/kg.

Repeated introduction a rokuroniya of bromide or a vekuroniya of bromide after immediate elimination of neuromuscular blockade (16 mg/kg of a sugammadeks)

In rare instances when immediate elimination of the neuromuscular block is necessary, the recommended period for repeated introduction of muscle relaxants makes 24 h.

If there is a need for neuromuscular blockade before the expiration of this time, nonsteroid muscle relaxants have to be applied.

The beginning of action of the depolarizing muscle relaxant can be slower, than it is supposed because a considerable part of postsynaptic nicotinic receptors can be still busy with a muscle relaxant.

Renal failure. Сугаммадекс it is not recommended to use for patients with heavy disturbance of renal function, including at patients who need carrying out dialysis.

The interactions caused by long action a rokuroniya of bromide or a vekuroniya of bromide. It is necessary to pay attention in the application instruction a rokuroniya of bromide or a vekuroniya of bromide to the list of drugs which exponentiate neuromuscular blockade. If resuming of neuromuscular blockade is observed, IVL and repeated introduction of a sugammadeks can be required.

Anesthesia complications. When recovery of neuromuscular conductivity was carried out intentionally during anesthesia, signs of surface anesthesia were occasionally noted (the movements, cough, grimaces).

If elimination of neuromuscular blockade is made during anesthesia, introduction of additional doses of anesthetics and/or opioids can be required.

Abnormal liver function. Сугаммадекс it is not metabolized in a liver therefore researches on patients with the broken function of a liver were not conducted. At use of drug for patients with heavy abnormal liver functions it is necessary to observe extra care. If the liver failure is followed by the coagulopathy phenomena, see special instructions at influence on a homeostasis.

Use of a sugammadeks in the conditions of an intensive care. Use of a sugammadeks for the patients receiving a rokuroniya bromide or a vekuroniya bromide in the conditions of intensive care unit was not studied.

Use of a sugammadeks for elimination of the neuromuscular blockade caused by other muscle relaxants (not a rokuroniya bromide or a vekuroniya bromide)

Сугаммадекс it should not be applied to elimination of blockade of the neuromuscular conductivity caused by such muscle relaxants as succinylcholine or connections of a benzylisoquinolinic row.

Сугаммадекс it is not necessary to apply to elimination of the neuromuscular blockade caused by other steroid muscle relaxants as data on efficiency and safety for such use are absent. There are only limited data on elimination of blockade of the neuromuscular conductivity caused a pankuroniya by bromide, however their insufficient quantity does not allow to recommend сугаммадекс for recovery of neuromuscular conductivity in case of use of this muscle relaxant.

The slowed-down recovery. At the states connected with lengthening of time of circulation (cardiovascular diseases, advanced age, a renal and liver failure), time of recovery of neuromuscular conductivity can increase.

Hypersensitivity reactions. The doctor has to be ready to emergence of possible reactions of hypersensitivity and has to observe necessary precautionary measures.

The patients who are on a diet with controlled consumption of sodium. Each ml of solution contains 9.7 mg of sodium. A dose of sodium, equal 23 mg, it is possible to consider as not containing sodium. If it is necessary to enter more than 2,4 ml of solution, then it should be considered at the patients who are on a diet with limited consumption of sodium.

Influence on a hemostasis. In experiments of in vitro additional increase in AChTV and prothrombin time at use of a sugammadeks with indirect anticoagulants, unfractionated heparin, low-molecular heparins, rivaroksabany and dabigatrany was revealed. In researches caused prolongation of the AChTV srednemaksimalny values in volunteers of a dose of a sugammadeks of 4 and 16 mg/kg for 17% and 22% respectively, and values of a prothrombin time (MHO) - for 11-22% respectively. This limited prolongation of AChTV and prothrombin time (MHO) had short-term character (≤30 min.).

On the present of clinically significant influence of a sugammadeks (in the form of monotherapy or in a combination with these anticoagulants) on frequency peri-or postoperative bleedings it is not revealed.

In view of the short-term nature of limited increase in AChTV and prothrombin time caused sugammadeksy (in the form of monotherapy or in a combination with the above-stated anticoagulants), it is improbable that сугаммадекс increased risk of bleedings. As currently there is no information on use of a sugammadeks for patients with coagulopathies, at them it is necessary to monitorirovat carefully coagulation parameters according to standard clinical practice.

After cultivation of a sugammadeks infusion solutions physical and chemical stability of drug remains during 48 h at a temperature from 2 ° to 25 °C. When opening the bottle containing сугаммадекс it is necessary to follow rules of an asepsis strictly. Administration of drug needs to be begun immediately. If сугаммадекс it is applied it is delayed, then observance of time and storage conditions before its use is on responsibility of the doctor. If cultivation was made in uncontrollable and nevalidirovanny aseptic conditions, then storage time of divorced solution should not exceed 24 h at a temperature from 2 ° to 8 °C.

Any remains of contents of bottles of infusional lines after use of a sugammadeks have to be destroyed according to the requirements accepted in this region.

Influence on ability to driving of motor transport and to control of mechanisms. It is necessary to avoid performance of potentially dangerous types of activity demanding the high speed of psychomotor reactions, such as driving of the car or control of mechanisms.


Side effects:

Most often (≥1/100 to <1/10): anesthesia complications.

Using a sugammadeks connect the following undesirable reactions.

s020.radikal.ru/i701/1602/89/06bbdbbd08ce.png

Complications when carrying out anesthesia. Emergence of a physical activity, cough during anesthesia or during the operative measure that reflects recovery of neuromuscular function.

Inadvertent preservation of consciousness during anesthesia. At the patients receiving сугаммадекс in some cases inadvertent recovery of consciousness is noted during anesthesia. However communication with introduction of a sugammadeks was regarded as improbable.

Resuming of neuromuscular blockade. Frequency of resuming of blockade which was estimated by means of monitoring of neuromuscular conductivity made 2% after use of a sugammadeks. However this frequency was noted in cases of introduction of a suboptimal dose of a sugammadeks (less than 2 mg/kg).

Hypersensitivity reactions. Reactions of hypersensitivity after use of a sugammadeks, including and anaphylactic, were observed at several people, including at volunteers. During clinical trials at the patients who are exposed to surgical treatment, the specified reactions met seldom, and data on the frequency of development of similar reactions after intake of drug in sale are absent.

Clinical manifestations of reactions of hypersensitivity varied from isolated skin before serious system reactions (i.e. an anaphylaxis, an acute anaphylaxis) and were noted at patients who did not receive сугаммадекс earlier.

The symptoms accompanying these reactions can include reddening, urticaria, erythematic rash, sharp decrease in the ABP, tachycardia, a paraglossa and throats. Heavy reactions of hypersensitivity can be fatal.

Information about healthy volunteers. At use of a sugammadeks hypersensitivity reactions, including anaphylactic were observed. In a research at healthy volunteers (placebo, n=150; 4 mg/kg, n=148; 16 mg/kg, n=150) reactions of hypersensitivity were observed in group of 16 mg/kg and is rare in group of 4 mg/kg or placebo.

In this research were also noted the dozozavisimy nature of a dysgeusia, nausea and reddening of integuments.

Patients with diseases of lungs. When maintaining patients with complications from lungs in the anamnesis the doctor always has to remember a possibility of development of a bronchospasm.


Interaction with other medicines:

Interaction as binding (hormonal contraceptives). Owing to introduction of a sugammadeks efficiency of some medicines can decrease because of decrease in their (free) plasma concentration. In such situation it is necessary or to administer repeatedly this medicine, or to appoint therapeutic equivalent medicine (preferably other chemical class).

Interaction owing to replacement of a muscle relaxant from a complex with sugammadeksy. Owing to administration of some medicines after use of a sugammadeks theoretically a rokuroniya bromide and a vekuroniya bromide can be forced out from a complex with sugammadeksy therefore resuming of neuromuscular blockade can be observed. In such cases it is necessary to resume use of IVL. Infusional administration of the drug which led to replacement a rokuroniya of bromide or a vekuroniya of bromide from a complex with sugammadeksy should be stopped. If development of interaction as replacement after parenteral administration of other medicine (which was made during 6 h after use of a sugammadeks) is supposed, it is necessary to carry out constant control behind the level of neuromuscular conductivity regarding identification of signs of resuming of blockade. Interactions as replacement are possible after administration of the following medicines: toremifena, flukloksatsillin and fuzidovy acid.

Clinically significant pharmakodinamichesky interaction with other medicines can be expected:

— for a toremifen, a flukloksatsillin and fuzidovy acid interactions as replacement are not excluded (clinically significant interaction as binding is not expected);

— for hormonal contraceptives the possibility of interaction as binding is not excluded (clinically significant interaction as replacement is not expected).

The interaction which is potentially influencing efficiency of a sugammadeks. Toremifen who has rather high constant of binding and rather high plasma concentration is capable to force out somewhat a vekuroniya bromide or a rokuroniya bromide from a complex with sugammadeksy. Therefore recovery of the relation of T4/T1 to 0.9 can be slowed down at patients who received торемифен in day of operation.

Administration of fuzidovy acid in the preoperative period can lead to some delay of recovery of TOF (T4/T1) of the relation to 0.9. However in the postoperative period development of a rekurarization as the speed of infusion of fuzidovy acid makes more than several hours, and its cumulation in blood - more than 2-3 days is not supposed.

The interactions which are potentially influencing efficiency of other drugs. Hormonal contraceptives. Interaction between sugammadeksy (4 mg/kg) and progesterone can lead to decrease in exposure of progestogen (34% of AUC) which is similar to the decrease observed at reception of a daily dose of an oral contraceptive on 12 h later than usual that, in turn, can lead to decrease in efficiency of contraception. For estrogen it is possible to expect decrease in effect also. Therefore introduction of a bolyusny dose of a sugammadeks is considered as equivalent to one passed daily dose of the oral hormonal contraceptives (combined or containing only progestogen). If the oral contraceptive was accepted in day of use of a sugammadsks, it is necessary to address the section of the application instruction of oral contraceptives describing actions at the admission of a dose.

In case of use of the hormonal contraceptives having a way of introduction, excellent from peroral the patient has to use an additional non-hormonal contraceptive method during the next 7 days and apply for information to the application instruction of this contraceptive.

Influence on laboratory indicators. In general сугаммадекс does not exert impact on laboratory tests behind a possible exception of the test by quantitative definition of progesterone in blood serum.

Pharmaceutical incompatibility. The drug Braydan® should not be mixed with other drugs and solutions except for recommended. If the drug Braydan® is administered through the uniform infusional line with other medicines, it needs to be washed out (for example, 0.9% chloride sodium solution) between use of the drug Braydan® and other drugs.

Physical incompatibility of a sugammadeks was observed with verapamil, ondansetrony and ranitidine.


Contraindications:

renal failure of heavy degree (KK <30 ml/min.);

— heavy liver failure;

— pregnancy;

— breastfeeding period;

— children's age up to 2 years;

— hypersensitivity to drug components.


Overdose:

So far one message on accidental overdose of drug in a dose of 40 mg/kg is received. Any considerable side effects were absent. Сугаммадекс it is well transferred in doses to 96 mg/kg with lack of any side effects connected or not connected with a dose.

Treatment: removal of a sugammadeks from a blood-groove by means of a hemodialysis using the filter with high hydraulic permeability, but not the filter with low hydraulic permeability is possible. On the basis of clinical trials after the 3-6-hour session of a hemodialysis with the filter with high hydraulic permeability concentration of a sugammadeks in plasma decreases approximately by 70%.


Storage conditions:

Drug should be stored in the unavailable to children, protected from light place, at a temperature from 2 °C to 8 °C. Not to freeze. A period of validity - 3 years.


Issue conditions:

According to the recipe


Packaging:

2 ml - bottles of colourless glass (10) - a pack cardboard.
5 ml - bottles of colourless glass (10) - a pack cardboard.



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