Source: Health Products and Food Branch (CA) Revision Year: 2018
Panhematin – Hemin for Injection.
PANHEMATIN (hemin for injection) is an enzyme inhibitor derived from processed red blood cells. This product is prepared from large pools of human red blood cells which may contain the causative agents of hepatitis and other viral diseases (See Warnings and Precautions).
Table 2. Dosage Forms, Strengths, Composition and Packaging:
| Route of Administration | Dosage Form/Strength/Composition | Non-medicinal Ingredients |
| Intravenous (IV) Infusion | Sterile Powder for Reconstitution for Injection, 268 mg/vial | Sodium carbonate and sorbitol. |
PANHEMATIN is formatted as a sterile, lyophilized powder for intravenous administration after reconstitution. Each dispensing vial of PANHEMATIN contains the equivalent of 268 mg hemin, 240 mg sodium carbonate and 335 mg of sorbitol. The pH may have been adjusted with hydrochloric acid. When mixed as directed with Sterile Water for Injection, USP, each 48 mL provides the equivalent of approximately 261 mg hematin (5.4 mg/mL). The product contains no preservatives.
PANHEMATIN is supplied as a sterile, lyophilized black powder in single dose dispensing vials in a carton.
The vial stopper contains natural rubber latex.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Recordati Rare Diseases Canada Inc., Toronto, Ontario, Canada, M4N 3N1 Distributed by: Recordati Rare Diseases Canada Inc., Oakville, ON, Canada, L6M 2W2 212276 |
Date of approval:
July 13, 2018 |
| Drug | Countries | |
|---|---|---|
| PANHEMATIN | Brazil, Canada |
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