Alglucosidase alfa Artificial Enzyme

Indications & Dose:

Contraindications:

Side Effects:

Common or very commonAgitation . anaphylaxis . antibody formation . blood pressure changes . bronchospasm . chest discomfort . cold extremities . cough . cyanosis . diarrhoea .dizziness . facial oedema . fatigue . flushing . headache .hypersensitivity reactions . injection-site reactions .irritability . muscle spasm . myalgia . nausea . paraesthesia .pruritus . pyrexia . rash . restlessness . sweating .tachycardia . tachypnoea . tremor . urticaria . vomiting Frequency not known Infusion-related reactions .necrotising skin lesions . severe skin reactions . ulcerativeskin lesions

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Lactations:

BREASTFEEDING Avoid—no information available.

MONITORING 

Monitor closely if cardiac dysfunction. Monitor closely if respiratory dysfunction. Monitor immunoglobulin G (IgG) antibody concentration.

DIRECTIONS FOR ADMINISTRATION For intravenous infusion give intermittently in Sodium chloride 0.9%;reconstitute 50 mg with 10.3mL water for injections toproduce 5 mg/mL solution; gently rotate vial withoutshaking; dilute requisite dose with infusion fluid to give afinal concentration of 0.5–4 mg/mL; give through a lowprotein-binding in-line filter (0.2 micron) at an initial rateof 1 mg/kg/hour increased by 2 mg/kg/

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