Product Description

PlasmaRho-D I.V. is a sterile non-pyrogenic aqueous solution, containing 150 μg /mL (1500 I.U. in 2mL) of immune globulin Anti-D. PlasmaRho-D I.V. is prepared from pooled Human venous plasma with a high content of Anti-D antibodies by ion-exchange column chromatography.

Each unit of plasma and each plasma pool used in the manufacture of this product has been tested and found to be negative / non-reactive to Hepatitis B surface Antigen (HBsAg), anti-HIV I-II and anti-HCV. Additionally, the plasma is tested by NAT method for HAV, HIV, HBV, and HCV and to contain <104 I.U. / mL Parvovirus B-19. Also, the manufacturing process includes a Solvent/Detergent step and Heat-treatment for inactivation of non-enveloped viruses.

Indications

• Non-splenectomised Rho (D) – positive adults with chronic ITP, children with chronic or acute ITP, and patients with thrombocytopenia secondary to HIV infection
• Clinical situations requiring an increase in platelet count to prevent excessive haemorrhage

Storage

• Store at 2°C to 8°C
• Do not freeze.

Shelf-life

36 months from the date of manufacture