SUGAMMADEX 100mg/ml, 2ml, vial

STD DINJSUGM2V-

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The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
V03AB35
Anatomical Therapeutic Chemical Classification according to WHOCC
The order of this product needs to be justified and is only acceptable under certain conditions.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.

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SUGAMMADEX

Therapeutic Action

Selective relaxant-binding agent

Antagonist to non-depolarizing neuromuscular blocking agents

Indications

Reversal of neuromuscular blockade induced by rocuronium or vecuronium only.

Sugammadex is superior to neostigmine and considered the first-line treatment in the following situations:

  • As rescue therapy in rare but life-threatening “cannot intubate, cannot ventilate” situation when rocuronium was used
  • For operations terminated prematurely, soon after a profound depth of neuromuscular blockade has been induced
  • In intubated or extubated patients who are not adequately reversed with neostigmine
  • In patients with contraindications to other reversal agents

Treatment with neostigmine presents limitations that may prevent the rapid reversal of neuromuscular blockade when needed.

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Instructions for use

Must be given into the IV infusion line as a single rapid bolus over 10 seconds. The IV line should be flushed prior to and post administration (Flush-Dose-Flush).

In paediatric patients, dilute in 0.9% NaCl to a concentration of 10 mg/mL.

Must only be administered by/under supervision of an anaesthetist.

Posology:

  • Monitor for twitch responses to determine the timing and dose for sugammadex administration:
    • 2 mg/kg if spontaneous recovery has occurred up to at least the reappearance of T2 on TOF
    • 4 mg/kg TOF = 0 but recovery has reached at least 1 - 2 post tetanic counts.
    • 16 mg/kg for immediate reversal of rocuronium (less reliable for vecuronium)
  • If required, wait 4 hours before re-administering rocuronium or vecuronium after up to 4 mg/kg sugammadex. After 16 mg/kg or with severe renal impairment, wait 24 hours.

Reversal of non-depolarizing muscle relaxants (vecuronium, rocuronium) with sugammadex should be monitored using a peripheral nerve stimulator.

Systematically order the corresponding pre-printed label to identify the syringe containing the product.

Sugammadex should be ordered together with rocuronium.

Precautions for Use

Not recommended in patients with severe renal impairment (CrCl <30 ml/min).

Use with caution in women on hormonal contraceptives (oral or implanted), as sugammadex may decrease progesterone levels. Advise additional contraception for at least 7 days.

Adverse reactions:

  • rare cases: flushing, urticarial rash, bronchospasm, prolonged QTc
  • coagulation effect: activated partial thromboplastin time (APTT) and prothrombin time (PT) prolonged by 17-22% for up to 30 minutes.
  • laryngeal spasm: strong vocal cord adduction lasting 2 - 3 minutes in non-intubated patients post-reversal.

Sugammadex is not compatible with verapamil, ranitidine and ondansetron.

Storage

  • Below 25ºC - Protect from sunlight
  • Do not freeze.