Label Changes for:
Zemuron (rocuronium bromide) Injection
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2010
- Quelicin (succinylcholine chloride injection, USP)
- Anectine (succinylcholine chloride injection, USP)
- Mivacron (mivacurium chloride) Injection
- Nuromax (doxacurium chloride) Injection
- Raplon (rapacuronium bromide) Injection
- Nimbex (cisatracurium besylate) Injection
- Zemuron (rocuronium bromide) Injection
- Norcuron (vecuronium bromide) Injection
- Arduan (pipecuronium bromide) Injection
- Pavulon (pancuronium bromide) Injection
WARNINGS AND PRECAUTIONS
Severe anaphylactic reactions to neuromuscular blocking agents, have been reported. These reactions have, in some cases, been life threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents, since crossreactivity between neuromuscular blocking agents, both depolarizing and nondepolarizing, has been reported.