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Sugammadex (Bridion)

Trade Name : BRIDION

Merck Sharp & Dohme Corp.

INJECTION, SOLUTION

Strength 100 mg/mL

SUGAMMADEX SODIUM gamma-Cyclodextrins [CS]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sugammadex (Bridion) which is also known as BRIDION and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 100 mg/mL per ml. Read more

Sugammadex (Bridion) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
  • BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. ()
  • BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
  • Doses and timing of BRIDION administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred.
  • Administer BRIDION intravenously as a single bolus injection. The bolus injection may be given over 10 seconds, into an existing intravenous line. BRIDION has only been administered as a single bolus injection in clinical trials.
  • From the time of BRIDION administration until complete recovery of neuromuscular function, monitor the patient to assure adequate ventilation and maintenance of a patent airway. Satisfactory recovery should be determined through assessment of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation.
  • The recommended dose of BRIDION does not depend on the anesthetic regimen.
  • Monitor for twitch responses to determine the timing and dose for BRIDION administration. ()
  • Administer as a single bolus injection. ()n n
  • 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation. ()
  • 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation. ()n n
  • 16 mg/kg is recommended if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. ()
  • BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. BRIDION is available as follows:
  • 200 mg/2 mL (100 mg/mL) in a single-dose vial for bolus injection ()
  • 500 mg/5 mL (100 mg/mL) in a single-dose vial for bolus injection ()
  • BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex .
  • Known hypersensitivity to sugammadex or any of its components. ()
  • No data
  • Anaphylaxis
  • Marked Bradycardia
  • Respiratory Function Monitoring
  • Waiting Times for Re-Administration of Neuromuscular Blocking Agent
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions (reported in u226510% of patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than the placebo rate): vomiting, pain, nausea, hypotension, and headache. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Toremifene
  • Hormonal contraceptives
  • No data
  • Pediatrics
  • Severe Renal Impairment
  • In premarketing clinical trials, one case of accidental overdose with 40 mg/kg BRIDION was reported without significant effects.
  • BRIDION can be removed using hemodialysis with a high-flux filter, but not with a low-flux filter. Based upon clinical studies, BRIDION concentrations in plasma are reduced with a high-flux filter by about 70% after a 3- to 6-hour dialysis session.
  • BRIDION (sugammadex) injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as n n (1:8) with a molecular weight of 2178.01. The structural formula is:
  • BRIDION is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg.
  • BRIDION may contain up to 7 mg/mL of the mono OH-derivative of sugammadex . This derivative is chemically designated as n n salt (1:7) with a molecular weight of 2067.90. The structural formula is:
  • No data
  • No data
  • No data
  • BRIDION (sugammadex) injection is a clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. BRIDION is available in the following presentations:
  • The packaging of this product is not made with natural rubber latex.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) (see USP Controlled Room Temperature). Protect from light. When not protected from light, the vial should be used within 5 days.
  • No data
  • Distributed by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2015-2018 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk8616-soi-1812r004
  • NDC 0006-5423-12
  • Bridionn n- 200 mg/2 mL
  • Rx only
  • For Intravenous Use Only
  • NDC 0006-5425-15
  • Bridionn n- 500 mg/5 mL
  • Rx only
  • For Intravenous Use Only

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