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  0.5% Teat Dip | Janssen Biotech, Inc.

  

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  2.1 Dosage

  SYLVANT 11 mg/kg is given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.

  Perform hematology laboratory tests prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter. If treatment criteria outlined in Table 1 are not met, consider delaying treatment with SYLVANT. Do not reduce dose.

  Table 1: Treatment Criteria Laboratory parameter Requirements before first SYLVANT administration Retreatment criteria * SYLVANT may increase hemoglobin levels in MCD patients Absolute Neutrophil Count ≥1.0 × 109/L ≥1.0 × 109/L Platelet count ≥75 × 109/L ≥50 × 109/L Hemoglobin* <17 g/dL <17 g/dL

  Do not administer SYLVANT to patients with severe infections until the infection resolves.

  Discontinue SYLVANT in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.

  2.2 Instructions for Preparation and Administration

  Use aseptic technique for reconstitution and preparation of dosing solution.

  1. Calculate the dose (mg), total volume (mL) of reconstituted SYLVANT solution required and the number of vials needed. A 21-gauge 1½ inch needle is recommended for preparation. Infusion bags (250 mL) must contain Dextrose 5% in Water and must be made of polyvinyl chloride (PVC), or polyolefin (PO), or polypropylene (PP), or polyethylene (PE). Alternatively PE bottles may be used.

  2. Allow the vial(s) of SYLVANT to come to room temperature over approximately 30 minutes. SYLVANT should remain at room temperature for the duration of the preparation.

  3. Aseptically reconstitute each SYLVANT vial as instructed in Table 2.

  Table 2: Reconstitution Instructions Strength Amount of Sterile Water for Injection, USP required for reconstitution Post-reconstitution concentration 100 mg vial 5.2 mL 20 mg/mL 400 mg vial 20 mL 20 mg/mL

  Gently swirl the reconstituted vials to aid the dissolution of the lyophilized powder. DO NOT SHAKE or SWIRL VIGOROUSLY. Do not remove the contents until all of the solids have been completely dissolved. The lyophilized powder should dissolve in less than 60 minutes.

  Once reconstituted, and prior to further dilution, inspect the vials for particulates and discoloration. Do not use if particles or solution discoloration are present or if visibly opaque. The reconstituted product should be kept for no more than two hours prior to addition into the infusion bag.

  4. Dilute the reconstituted SYLVANT solution dose to 250 mL with sterile Dextrose 5% in Water by withdrawing a volume equal to the total calculated volume of reconstituted SYLVANT from the Dextrose 5% in Water, 250 mL bag. Slowly add the total calculated volume (mL) of reconstituted SYLVANT solution to the Dextrose 5% in Water infusion bag. Gently invert the bag to mix the solution.

  5. Administer the diluted SYLVANT solution in 5% Dextrose in Water 250 mL by intravenous infusion over a period of 1 hour using administration sets lined with PVC, or polyurethane (PU), or PE, containing a 0.2-micron inline polyethersulfone (PES) filter. The infusion should be completed within 4 hours of the dilution of the reconstituted solution to the infusion bag.

  6. Do not infuse SYLVANT concomitantly in the same intravenous line with other agents.

  7. Do not store any unused portion of the reconstituted product or of the infusion solution. Waste material should be disposed of in accordance with local requirements.

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