GALSULFASE IV (NAGLAZYME) HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Refrigerate at 2-8 C (36-45 F). * DO NOT freeze or shake. * PRESERVATIVE FREE formulation: Use immediately after reconstitution. * Flush IV line both prior to and after administration of medication. * Do not administer medication IV concomitantly with any other medication through same site and or tubing. * Pretreatment with antihistamines with or w/out antipyretics is recommened 30 to 60 minutes prior to start of infusion. WARNINGS/PRECAUTIONS: TOP * There are no adequate or well-controlled safety studies in pregnant women. NOTIFY YOUR DOCTOR IF PREGNANT or intend to become pregnant. * Report any side effects immediately to your physician (rash, erythema, edema pruritus, etc.) * SPECIAL POPULATIONS: * Pediatric: The safety and efficacy of this medicine in children younger than 5 years of age has not been established. * It is not known if this drug is excreted in breast milk. Notify your doctor if you are breastfeeding. Other Common Side Effects: TOP Severe skin itching with patches; Narrowing of airway passage; Headache; Fever; Vomiting; Respiratory depression; Absence of breathing during sleep; Upper respiratory infection; Cough; Stomach discomfort or pain; Diarrhea; Ear pain; Eye inflammation; High blood pressure. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved