DOSAGE AND ADMINISTRATION
Before administering hemin for injection, an appropriate period of alternate therapy (i.e., 400 g glucose/day for 1 to 2 days) must be considered. If improvement is unsatisfactory for the treatment of acute attacks of porphyria, an intravenous infusion of PANHEMATIN containing a dose of 1 to 4 mg/kg/day of hematin should be given over a period of 10 to 15 minutes for 3 to 14 days based on the clinical signs. In more severe cases this dose may be repeated no earlier than every 12 hours. No more than 6 mg/kg of hematin should be given in any 24-hour period.
After reconstitution each mL of PANHEMATIN contains the equivalent of approximately 7 mg of hematin. The drug may be administered directly from the vial.
| Dosage Calculation Table |
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1 mg hematin equivalent = 0.14 mL PANHEMATIN
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2 mg hematin equivalent = 0.28 mL PANHEMATIN
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3 mg hematin equivalent = 0.42 mL PANHEMATIN
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4 mg hematin equivalent = 0.56 mL PANHEMATIN
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Since reconstituted PANHEMATIN is not transparent, any undissolved particulate matter is difficult to see when inspected visually. Therefore, terminal filtration through a sterile 0.45 micron or smaller filter is recommended. Preparation of Solution:
Reconstitute PANHEMATIN by aseptically adding 43 mL of Sterile Water for Injection, USP, to the dispensing vial. Immediately after adding diluent, the product should be shaken well for a period of 2 to 3 minutes to aid dissolution. NOTE: Because PANHEMATIN contains no preservative and because PANHEMATIN undergoes rapid chemical decomposition in solution, it should not be reconstituted until immediately before use. After the first withdrawal from the vial, any solution remaining must be discarded.
No drug or chemical agent should be added to a PANHEMATIN fluid admixture unless its effect on the chemical and physical stability has first been determined.
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