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Octapharma USA - Products
The following information is intended for use by customers, patients, and health care professionals in the
United States
. Countries outside the
United States
may have regulatory, legal requirements, or medical practices which are different than those in the
United States
and may require additional information. Therefore, this information may not be appropriate for use outside the
United States
.
octagam® 5% [Immune globulin intravenous (human) 5% solvent/detergent treated] was approved by the US Food and Drug Administration in May 2004.
octagam® is indicated for the treatment of primary immune deficient diseases, such as: congenital agammaglobulinemia and hypogammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. In replacement therapy for PID, octagam® provides a broad spectrum of IgG antibodies against bacterial and viral pathogens.
octagam® is supplied as a ready-to-use liquid and requires no filtration prior to intravenous infusion. It is available in 1g, 2.5g, 5g,10g and 25g single use bottles. octagam® can be stored at room temperature or be frefrigerated for up to 24 months. octagam® is sucrose, fructose, and preservative free.
Related Documents:
Full Prescribing Information for octagam® 5%
Important Maltose Warning Letter, Oct 19, 2005
octagam® Important Safety Information
albumin (Human) 5% was approved by the US Food and Drug Administration in October 2006.
albumin (Human) 5% is indicated for the restoration and maintenance of circulating blood volume for:
- Hypovolemia
- Hypoalbuminemia
- Prevention of central volume depletion after paracentesis due to cirrhotic ascites
albumin (Human) 5% is supplied in 5g (100ml), 12.5g (250ml) and 25g (500ml) single use bottles. It may be stored for 36 months at room temperature (+2°C to 25°C/ 36°F to 77°F).
Related Documents:
Important Safety Information
Full Prescribing Information
albumin (Human) 25% was approved by the US Food and Drug Administration in October 2006.
albumin (Human) 25% is indicated for the restoration and maintenance of circulating blood volume for:
- Hypovolemia
- Hypoalbuminemia
- Prevention of central volume depletion after paracentesis due to cirrhotic ascites
- Ovarian hyperstimulation syndrome (OHSS)
- Adult respiratory distress syndrome (ARDS)
- Acute nephrosis
- Hemolytic Disease of the Newborn (HDN)
albumin (Human) 25% is supplied in 12.5g (50ml) and 25g (100ml) single use bottles. It may be stored for 36 months at room temperature (+2°C to 25°C/ 36°F to 77°F).
Related Documents:
Important Safety Information
Full Prescribing Information
albumin (Human) 20% was approved by the US Food and Drug Administration in September 2007.
albumin (Human) 20% is indicated for the restoration and maintenance of circulating blood volume for:
- Hypovolemia
- Hypoalbuminemia
- Prevention of central volume depletion after paracentesis due to cirrhotic ascites
- Ovarian hyperstimulation syndrome (OHSS)
- Adult respiratory distress syndrome (ARDS)
- Acute nephrosis
- Hemolytic Disease of the Newborn (HDN)
albumin (Human) 20% is supplied in 10.0g (50ml) and 20g (100ml) single use bottles. It may be stored for 36 months at room temperature (+2°C to 25°C/ 36°F to 77°F).
Related Documents:
Important Safety Information
Full Prescribing Information
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