#rocuronium

Rocuronium Bromide Suppliers in India: A Key Element in Anesthesia Care

Introduction

Rocuronium bromide is a widely used muscle relaxant that plays an essential role in anesthesia. It is commonly used in medical procedures to induce muscle relaxation, facilitating endotracheal intubation and improving surgical conditions. This non-depolarizing neuromuscular blocker is considered a crucial component of anesthesia protocols in both major surgeries and intensive care units (ICUs). Given the growing demand for Rocuronium bromide in the Indian healthcare sector, the market for its suppliers in India is expanding rapidly. This blog will explore the landscape of Rocuronium bromide suppliers in India, their role in ensuring quality care, and what factors healthcare professionals should consider when sourcing this critical drug.

What is Rocuronium Bromide?

Rocuronium bromide belongs to the class of non-depolarizing muscle relaxants, which work by blocking the acetylcholine receptors at the neuromuscular junction. By inhibiting acetylcholine's action, Rocuronium induces muscle paralysis, which is particularly useful in surgeries or procedures that require the patient to remain still. Unlike other muscle relaxants, Rocuronium has a rapid onset and intermediate duration of action, making it ideal for intubation and short-to-medium duration surgeries.

It is often used as an alternative to succinylcholine in rapid sequence intubation (RSI) and can be reversed with a cholinesterase inhibitor like neostigmine if needed. The drug has a favorable safety profile when administered correctly, although it must be used under professional supervision in clinical settings.

The Role of Rocuronium Bromide Suppliers in India

India, being one of the world’s largest producers of generic medicines, has a vast network of pharmaceutical companies that supply Rocuronium bromide to various healthcare facilities. These suppliers play a pivotal role in maintaining the uninterrupted supply of this vital anesthetic agent to hospitals, surgical centers, and ICUs. They ensure that healthcare providers have access to a steady stream of high-quality, cost-effective drugs to meet the growing needs of patients.

Key Factors Influencing Rocuronium Supply in India

Quality Assurance: The pharmaceutical industry in India is governed by strict regulations set by the Central Drugs Standard Control Organization (CDSCO). Suppliers of Rocuronium bromide are required to adhere to Good Manufacturing Practices (GMP) to ensure the drug's efficacy, safety, and quality. This includes meeting international standards, ensuring that the active ingredients are pure, and performing extensive testing.

Regulatory Compliance: India’s regulatory framework ensures that Rocuronium bromide suppliers follow guidelines for production, distribution, and storage. Drugs intended for medical use are subjected to rigorous evaluation and approval processes. Companies that supply these drugs need to have a thorough understanding of the regulatory landscape to comply with national and international standards.

Import and Export Regulations: While India has a strong domestic production base for Rocuronium bromide, the country also imports significant quantities of this anesthetic. Suppliers must navigate customs regulations and import policies effectively to ensure a smooth supply chain. Moreover, India exports the drug to other regions, making it an essential player in the global market.

Pricing and Availability: With the rise in demand for anesthesia drugs across both private and government hospitals, pricing plays a major role in supplier selection. Rocuronium bromide suppliers often strive to offer competitive pricing without compromising on the quality of the product. Bulk purchasing agreements and strategic partnerships with hospitals can ensure better pricing models, making this vital drug more affordable for the Indian healthcare system.

Supply Chain Management: Efficient logistics and distribution networks are essential for suppliers to meet the demand for Rocuronium bromide. Suppliers must ensure that they have a robust supply chain management system in place to guarantee timely delivery, optimal storage, and proper handling of the product.

Leading Suppliers of Rocuronium Bromide in India

While we will refrain from mentioning specific companies, it’s important to highlight the types of organizations that play an instrumental role in supplying Rocuronium bromide:

Generic Pharmaceutical Manufacturers: Many Indian pharmaceutical companies specialize in manufacturing generic versions of internationally recognized drugs. These companies usually have a global presence and are known for offering affordable alternatives to branded medications. They are a primary source for bulk supplies of Rocuronium bromide.

Multinational Pharmaceutical Corporations: Large international companies with operations in India often supply both branded and generic versions of Rocuronium bromide. These companies typically offer comprehensive distribution networks and a range of anesthesia solutions, contributing to the overall availability of the drug.

Wholesale Distributors: These entities act as intermediaries between manufacturers and healthcare providers. They ensure the availability of Rocuronium bromide across hospitals, clinics, and pharmacies, and often play a significant role in making sure the supply chain remains uninterrupted.

Specialty Medical Supply Companies: These companies focus on providing specialized medical products, including anesthetic agents like Rocuronium bromide. They cater to hospitals and medical institutions with specific needs, offering customized solutions for procurement, storage, and usage.

Choosing the Right Supplier for Rocuronium Bromide

When sourcing Rocuronium bromide, healthcare providers must ensure that they select a supplier that meets the following criteria:

Reputation for Quality: The supplier should have a proven track record of providing high-quality pharmaceutical products. This is particularly important for anesthetics, as poor-quality drugs can have serious consequences for patient safety.

Reliable Delivery and Stock Management: Given the critical nature of the drug, it is crucial to have a supplier that can guarantee timely delivery and maintain an adequate stock at all times. Shortages or delays could disrupt hospital operations and patient care.

Customer Support and Technical Expertise: A supplier that offers comprehensive customer service, including technical support and training for healthcare professionals on the correct use of Rocuronium bromide, is highly valuable.

Compliance with Regulatory Standards: Only work with suppliers who can demonstrate compliance with Indian and international drug regulations. Certification from regulatory bodies like CDSCO and USFDA (if applicable) is a strong indicator of reliability and trustworthiness.

Competitive Pricing: Cost-effectiveness is always a key factor in the healthcare industry. Suppliers that offer reasonable prices for Rocuronium bromide without compromising on quality are highly sought after.

Conclusion

The supply of Rocuronium bromide in India is a critical component in ensuring safe and effective anesthesia care in hospitals and clinics across the country. As the healthcare industry continues to evolve and grow, so does the importance of reliable, quality suppliers. By selecting suppliers who meet regulatory standards, offer competitive pricing, and ensure the highest quality products, healthcare providers can ensure that they meet the needs of their patients while maintaining a high standard of care.

If you're a medical institution or a healthcare professional in need of Rocuronium bromide, it’s vital to do your due diligence in identifying trustworthy suppliers who can meet your needs and keep your operations running smoothly.

Rocuronium Bromide Suppliers In India

Rocuronium Bromide Suppliers in India: A Comprehensive Overview

It is widely used in hospitals and healthcare settings to facilitate intubation and provide muscle relaxation during surgeries. In India, the demand for Rocuronium Bromide has grown steadily due to the expanding healthcare infrastructure, increasing surgical procedures, and rising awareness of its benefits in anesthesia.

In this blog, we will explore the landscape of Rocuronium Bromide suppliers in India, highlighting the key factors driving the supply chain, market trends, and the regulatory environment that impacts its distribution.

The Role of Rocuronium Bromide in Anesthesia

Rocuronium Bromide is a medication primarily used for muscle relaxation during surgeries, facilitating easier intubation and reducing patient discomfort. It works by blocking the transmission of nerve impulses to muscles, leading to muscle paralysis. Unlike depolarizing agents such as succinylcholine, Rocuronium is considered safer for long procedures and is reversible, making it a preferred choice in many cases.

Market Demand for Rocuronium Bromide in India

The healthcare sector in India is experiencing rapid growth, thanks to advancements in medical technology, an increase in healthcare facilities, and the rising number of surgeries performed each year. Rocuronium Bromide, being an essential component of anesthesia protocols, is in consistent demand.

Several factors drive this demand:

Increased Surgical Procedures: With an aging population and a rise in chronic diseases, the number of surgeries (both elective and emergency) has increased. This directly impacts the demand for muscle relaxants like Rocuronium Bromide.

Growth in Anesthesia Use: As modern anesthesia techniques evolve, the demand for effective and safe muscle relaxants like Rocuronium Bromide has risen in hospitals and surgical centers.

Rising Healthcare Standards: India's healthcare industry is increasingly adopting international standards, with hospitals prioritizing the use of high-quality medications. Rocuronium Bromide meets these standards and is commonly stocked in leading hospitals.

Growth in Medical Tourism: India has become a hub for medical tourism, attracting patients from around the globe seeking high-quality, affordable healthcare. This international demand for medical procedures also contributes to the need for muscle relaxants like Rocuronium Bromide.

Key Suppliers of Rocuronium Bromide in India

India has a large number of suppliers catering to the pharmaceutical needs of hospitals and clinics. These suppliers range from multinational pharmaceutical companies to Indian manufacturers who provide high-quality drugs at competitive prices. The supply of Rocuronium Bromide in India is maintained through multiple channels:

Domestic Manufacturers: Several Indian pharmaceutical companies manufacture Rocuronium Bromide under various brand names. These manufacturers adhere to strict quality control processes and regulatory standards to ensure the safety and efficacy of their products.

International Pharmaceutical Companies: Multinational companies that have a presence in India also supply Rocuronium Bromide. These companies bring their global expertise in pharmaceutical manufacturing and contribute to the availability of high-quality products in the Indian market.

Distributors and Wholesalers: A well-established network of distributors and wholesalers ensures the widespread availability of Rocuronium Bromide in both urban and rural healthcare settings. These intermediaries play an essential role in bridging the gap between manufacturers and end-users.

Online Pharmaceutical Platforms: With the rise of e-commerce and online pharmaceutical services, many suppliers are now reaching a wider customer base through digital platforms. This has made it easier for hospitals and clinics to procure Rocuronium Bromide at competitive prices.

Regulatory Environment

The CDSCO ensures that drugs, including Rocuronium Bromide, are manufactured according to high safety standards and meet all regulatory requirements. Suppliers of Rocuronium Bromide must adhere to these guidelines to ensure their products are safe and effective.

India also follows strict good manufacturing practices (GMP), which manufacturers must comply with to ensure the production of safe and high-quality medicines. Internationally recognized certification, such as ISO and WHO-GMP, is often required for suppliers that want to sell their products in global markets.

Challenges Faced by Suppliers

Despite the growing demand for Rocuronium Bromide, suppliers in India face several challenges:

Price Sensitivity: Price is a critical factor in India’s healthcare market. While the demand for Rocuronium Bromide is high, cost-effective solutions are necessary to meet the budgetary constraints of hospitals, particularly in the public healthcare sector.

Regulatory Compliance: Adhering to the regulatory requirements set by the CDSCO and other international bodies can be challenging for smaller manufacturers and suppliers, especially in terms of quality control and documentation.

Supply Chain Disruptions: Like many other countries, India has faced supply chain disruptions, particularly due to global events like the COVID-19 pandemic. This has affected the timely availability of essential drugs, including Rocuronium Bromide, which can lead to shortages in some regions.

Future Trends in Rocuronium Bromide Supply

Looking forward, the supply of Rocuronium Bromide in India is expected to evolve in line with healthcare advancements and changing market dynamics. A few trends that may shape the future of Rocuronium Bromide supply include:

Increased Local Production: India’s emphasis on self-reliance and "Make in India" initiatives may encourage more local manufacturers to produce Rocuronium Bromide, reducing reliance on imports and potentially lowering costs.

Technological Advancements: As the pharmaceutical sector continues to innovate, suppliers may use advanced manufacturing technologies to produce Rocuronium Bromide more efficiently, ensuring its availability and quality.

Global Expansion: With India’s reputation as a global leader in pharmaceutical production, more suppliers may explore export opportunities, contributing to a wider global supply of Rocuronium Bromide.

Focus on Quality: As demand grows for high-quality pharmaceuticals, suppliers will need to continually invest in maintaining rigorous quality control standards to stay competitive in both domestic and international markets.

Conclusion

Rocuronium Bromide is an essential medication in modern anesthesia, and its suppliers in India play a pivotal role in the country’s healthcare infrastructure. With the growing demand for surgical procedures, increasing healthcare standards, and the rise of medical tourism, the market for Rocuronium Bromide continues to expand. Suppliers, both domestic and international, must navigate challenges like price sensitivity, regulatory compliance, and competition to meet the needs of hospitals and clinics across India.

As the pharmaceutical landscape in India continues to evolve, the future of Rocuronium Bromide supply looks promising, with increased local production, technological advancements, and a focus on high-quality standards driving the market forward.

Abstract

Introduction: Rocuronium is a aminosteroid structured, non-depolarizing neuromuscular blocking agents (NMB). Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Determinations of serum tryptase concentrations are interdisciplinary recommended in diagnosis of its adverse reactions. No studies have been performed to explain specific role of rocuronium doses on serum tryptase values. The aim of this study was to investigate the potential effect of rocuronium on serum tryptase concentrations.

Patients and method: The study included 126 women given a general volatile anesthesia: group I - 66 - using the rocuronium and group II - 60 - without neuromuscular relaxants. Information's about perioperative fluid therapy and doses of rocuronium were noticed. The blood samples were collected to perform tryptase concentration analysis: preoperatively - before anesthesia and postoperatively - after recovery from anesthesia.

Results: Median preoperatively serum tryptase concentration in group I was 2,92 and 3,27 mcg/L in group II, respectively. The reduction of serum tryptase value was noticed in both groups and attained the level of 2.60 mcg/L in group I and 2.79 mcg/L in group II after anesthesia, (p<0.05). Analysis did not show a correlation between the serum tryptase levels and the values connected to the administration of rocuronium and perioperative fluid therapy. No significant differences in the tryptase concentration between the groups were identified.

Conclusion: In conclusion, the scheme of volatile anesthesia with rocuronium did not induced any significant changes in tryptase serum levels compared with the volatile method. The study excluded the serum tryptase concentration dependence of rocuronium and crystalloid dilutional effect. The most likely explanation of our results are physiological changes and specific rhythm of fluctuations of tryptase secrection. It seems prudent to confirm the effect of rocuronium on serum tryptase on larger cohort of patients.

Keywords: Tryptase; Mast cell; Rocuronium

Introduction

Perioperative hypersensitivity and anaphylaxis are important issues in anesthesiology because its occurrence is related to drugs and agents used in general anesthesia [1-4]. The greatest risk of hypersensitivity occurs during anesthesia for female patients and it is connected with the induction phase using skeletal muscle relaxants [5-7]. Aminosteroids including rocuronium cause hypersensitivity much more often than isoquinoline derivatives and depolarizing agent. Due to the fact that no hypersensitivity to inhalational anesthetic agents has been shown only volatile induction and maintenance of anesthesia using an anesthetic sevoflurane does not pose a risk of hypersensitivity [8-9]. Rocuronium - modern, aminosteroid neuromuscular blocker agent has beneficial pharmacodynamic and pharmacokinetic profile. Many authors presented that rocuronium is very good alternative relaxant in Rapid Sequence Induction. Through the presence of sugammadex - specific antagonist of rocuronium, using of this relaxant agent minimize risk of postoperative respiratory failure. Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Due to the multiple advantages reports of triggering allergic or hypersensitivity reactions caused by rocuronium create doubts about the safety of application [10-12].

Determinations of serum tryptase concentrations are interdisciplinary recommended in diagnosis of its adverse reactions. Tryptase is the main serine protease stored and released by activated mast cells - effector cells triggering hypersensitivity and anaphylaxis. Measurements of serum tryptase concentration in normal condition according to the manufacturer's product information ranges are 1-11,4 mcg/L with the lower detection limit 1mcg/L [13-15]. No studies have been performed to explain specific role of rocuronium doses on serum tryptase values. The aim of this study was to investigate the potential effect of rocuronium on serum tryptase concentrations during general anesthesia.

Experimental

Patients

The study was approved by the Bioethical Committee of the Medical University of Bialystok UMB no. R-I-002/286/2009 and was conducted at the Clinic of Anesthesiology and Intensive Therapy of the Medical University of Bialystok. The research was conducted on 126 female patients with assessed perioperative risk according to the ASA 1-2 scale, without allergy related diseases, who were divided into two groups according to the method of anesthesia being used. The study was carried out on two groups of patients:

Group I - 66 patients qualifying for the gynecological operation procedures under general volatile anesthesia with the muscle relaxant - rocuronium.

Group II - 60 patients qualifying for thyroidectomy under general volatile anesthesia without NMB.

Methods of anesthesia

In the both groups volatile induction and maintenance of anesthesia with inhalational anesthetic sevoflurane (Sevorane, Abbvie) was performed. Analgesia was ensured through the administration of intravenous fractional doses of fentanyl at 2 mcg/kg of body mass (Fentanyl, Polfa S.A.). After the end of the surgical procedure the administration of sevoflurane was stopped and access to fresh gasses was increased. During the induction of anesthesia patients of Group I, after the attainment of adequate level of anesthetic sleep, a skeletal muscle relaxant rocuronium (Esmeron, Organon) was administered dosed at 0.6 mg/kg of body weight and neuromuscular monitoring of muscle function applying four consecutive stimuli or the TOF (Train-Of-Four) method through the TOF-Watch device. Tracheal intubation was performed after reaching a TOF response level of 0. When muscle function returned to TOF 4 continuous infusion of rocuronium at a speed required achieving TOF 0 was administered. The continuous infusion of rocuronium was stopped at the moment of surgical closing of the peritoneal cavity. After the appearance of respiratory movement and the return of neuromuscular function to the level of TOF 25% 0.5 mg of atropine (Atropinum sulfuricum, Polfa) and 1.5 mg of neostigmine (Polstygmina, Pliva) was administered intravenously. Extubation was performed in hemodynamically stable patients with preserved, normal spontaneous respiratory function at TOFR (TOF Ratio) of 0.8-0.9. In group II patients no skeletal muscle relaxants were used. After attaining adequate level of anesthetic sleep tracheal intubation was performed.

Serum tryptase concentration analysis

Blood samples were taken during the periooperative period to assess the level of tryptase in blood serum:

In group I the concentration of tryptase in blood serum was tested in samples taken before the administration of anesthesia, after stopping the infusion of rocuronium and at the end of administration of anesthesia.

In group II the concentration of tryptase in blood serum was determined from samples taken before and after the administration of anesthesia.

Determination of the concentration of tryptase in blood serum was performed using the immune fluoroenzymatic test UniCap Tryptase manufactured by Pharmacia Diagnostics AB.

Statistical Analysis

Conformity assessment of empirical distribution of studied parameters was performed using the Shapiro-Wilk test. Since most empirical distributions obtained differed significantly from normal distributions a comparison of the data was assessed by non-parametric tests. The differences in the levels of parameters obtained through the period of observation were assessed using the Wilcoxon signed-rank (paired difference) test and to determine the differences in the level of parameters being considered between the groups of patients the Mann-Whitney U test was used. Correlation coefficients were calculated using Spearman's rank method. Probability values of p < 0.05 were accepted as significant. Group data were expressed as means and standard deviations (SD) or as medians and range when appropiate. Obtained results were subjected to statistical analysis using the STATISTICA12.0 (Stat Soft Inc., Tulsa, OK, United States) software.

Results

Patients of both groups did not differ when considering their age and anthropometric characteristics (Table 1). The study ascertained that the concentration of serum tryptase in both groups of patients became significantly reduced after anesthesia (Figure 1 & 2). The median value of serum tryptase concentrations in group I was 2.92 mcg/L preoperatively and fell to the level of 2.60 mcg/L after anesthesia. The reduction of concentration of tryptase in serum was also noticed in group II and before anesthesia was at 3.27 mcg/L and attained the level of 2.79 mcg/L (p<0.05) after anesthesia. In group I the drop in the concentration of tryptase in blood serum after the finish rocuronium infusion and after the end of administering anesthetics was 10.62 and 10.96% (p<0.05), respectively. In group II the recorded decrease in the concentration of tryptase in blood serum after anesthesia reached 14.68% (p<0.05)

In two patients in group II postoperative serum tryptase concentrations were higher than 11,4 mcg/L. In this cases preoperative tryptase values were 20,40 and 19,10 mcg/L and decreased by 4,10 and 2,30 respectively. No significant differences in the concentration of tryptase in serum between the two groups of patients at various levels of anesthesia have been identified through the analysis (Figure 3). We did not show a correlation between the serum concentration and the values connected to the administration of rocuronium and parameters connected with fluid therapy. The concentration of tryptase both at the time of stopping the infusion of rocuronium as well as at the moment of ending anesthesia did not demonstrate a correlation with the administered intubation dose, the dose administered as an infusion or the total dose of that relaxant (Table 2 & 3).

Discussion

Perioperative hypersensitivity and anaphylaxis reactions are increasing and important subject in anesthesiology. Most reports come from West Europe, Scandinavia, New Zealand and Australia and in this countries incidence was estimated between 1:10 000 - 1:20 000, with mortality rate ranging 3.54.7%. Many authors have demonstrated that rocuronium is the neuromuscular blocking agent which causes anaphylaxis or hypersensitivity reactions the most often during general anesthesia. Hypnotic intravenous medicaments, opioids, antibiotics, latex, radiocontrast agents may also induce similar symptoms [2,3,4,7]. Only the volatile method of anesthesia using sevoflurane is not connected with any risk of inducing hypersensitivity reactions or anaphylaxis [1,6]. Many authors have described a female predominance, especially in adverse allergic reactions to muscle relaxants with the female: male ratio 8:1 to 3:1 [3,5-7].

Diagnosis of hypersensitivity reaction connected with neuromuscular blocking agents is complicated. Cross reactivity between myorelaxants groups are very common. Chemical and food allergies exhibit cross reactivity with other chemical groups of medicaments [16,17]. Confirmation of its adverse reactions should be based on measurements of serum tryptase concentrations and the identification of allergens using skin tests [6,18]. Determination of the serum tryptase value is a very important way of  diagnosis and is recommended by international multidisciplinary committees. Due to enzyme stability under different external environmental condition, tryptase determination is a reliable and effective method of confirming the occurrence of anaphylaxis [1-2].

The aim of this study was to investigate the potential effect of rocuronium on serum tryptase concentrations. To minimize the possible confounding from gender factor and make the study more helpful in clinical aspects the study group consisted of women undergoing a gynecological operation under general anesthesia with rocuronium and the control group - women undergoing a thyroidectomy under general anesthesia without using any neuromuscular blocking agents. The median value of serum tryptase concentrations were in group I 2.92 mcg/L and in group II 3.27 mcg/L, respectively. Comparing preoperative and postoperative serum tryptase values a significant decrease of 0.23 in group I and 0.61 in group II, (p<0.05), was found. In the study we did not observe any symptoms of hypersensitivity reaction during general anesthesia and perioperative period.

Results of the study performed by Laroche et all demonstrated that mean serum tryptase levels in resuscitation during perioperative anaphylaxis was 86.5 mcg/L [19]. The results of our study are similar with Garvey's observations. After general anesthesia and orthopedic surgery serum tryptase concentration decreased from median value 4,07 to 3,45 mcg/L, giving variation 0,45. Garvey et all considering causes of decreasing serum tryptase concentration during general anesthesia presented a theory of dilutional effect of crystalloid fluids infusion [20]. Many authors have reported the role of intravenous infusion and oral intake on hematological blood parameters [21-23]. However, no such studies have been performed directly for serum tryptase concentrations. In our study no significant differences in fluid therapy between the two groups have been presented. In order to reduce the dilutional effect of crystalloid fluids infusion the blood samples were taken from isolated venopunctured site. Mean volume of intravenous crystalloid fluids administered during anesthesia in the group I was 1274.24 ml, in group II it was 1319.16 ml. Spearman’s analysis did not present any correlation between postoperative serum tryptase concentrations and the parameters of fluid therapy.

The changes of serum tryptase concentration in our study confirm Brown's at all observations. The authors explained that in absence of anaphylaxis serum tryptase values do not vary more than 2 mcg/L and specific rhythm in the changes of the concentration of serum tryptase fluctuates around 0.26 mcg/L [15]. No studies have been performed to explain specific effects of rocuronium doses for serum tryptase values. In our study group the mean intubation dose of rocuronium reached 56.06 mg, the mean dose given in infusion was 40.37 mg, while the mean total dose was 96.43 mg and the postoperative serum tryptase concentrations did not correlate with parameters of rocuronium doses.

Conclusion

In conclusion, the study ascertained that the serum tryptase concentration in non- allergic female patients became significantly reduced after general anesthesia with rocuronium and the most likely explanation are physiological changes and specific rhythm of fluctuations. Perioperative serum tryptase concentrations did not correlate with parameters of rocuronium doses and parameters of fluid  therapy. The scheme of volatile anesthesia with rocuronium did not induce any statistical changes in tryptase serum levels compared with the volatile method. In women without suspected allergic medical history using of rocuronium as neuromuscular blocking agent during volatile general anesthesia is save. The limitation of our study was a relatively small number of patients examined, and it seems prudent to confirm the effect of rocuronium on serum tryptase on larger cohort of patients.

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