Active Substance: Botulinum A toxin-haemagglutinin complex.
Overview
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This medicine contains an important and useful components, as it consists of
Botulinum A toxin-haemagglutinin complexis available in the market in concentration
Clostridium Botulinum Toxin Type A Neurotoxin
Patient Monitoring for Administration Patients should be well hydrated prior to the initiation. Assess renal function, including the measurement of blood urea nitrogen (BUN) or serum creatinine prior to the initial infusion. Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential risk for developing acute renal failure. Increases in serum creatinine and BUN have been observed as soon as one to two days following treatment with other IGIV products. During administration, monitor the patient's vital signs continuously and observe the patient carefully for any associated symptoms. DO NOT EXCEED THE RECOMMENDED INFUSION RATE of 1 mL/kg/hour (50 mg/kg/h), and follow the infusion schedule closely . If a patient develops an infusion reaction, slow the rate of infusion immediately or temporarily interrupt the infusion.
Muscle spasm, Strabismus, Blepharospasm, Achalasia, Cervical dystonia, Limb spasticity, Overactive bladder, Chronic migraine, Severe Primary Axillary Hyperhidrosis, Glabellar and lateral Canthal lines (cosmetic purpose)
As with other immunoglobulin preparations, it should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations. Individuals with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin A.
Serious adverse reactions were not observed in clinical trials. The most common adverse reaction was skin rash. Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing were the most frequent adverse reactions observed during the clinical trials of similarly-prepared human IGIV products.
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Neurotoxin from Clostridium botulinum; prevents ACh release from presynaptic membrane, causing temporary calming of muscle contractions by blocking the transmission of nerve impulses.
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