SUMMARY
RhoGAM and MICRhoGAM Rho(D) Immune Globulin (Human) are sterile solutions containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D.
RhoGAM Ultra-Filtered PLUS (HUMAN IMMUNOGLOBULIN G) is indicated for the following:
1.1. Pregnancy and other obstetrical conditions
For administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are conclusively Rh-negative.
- Delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
- Antepartum prophylaxis at 26 to 28 weeks gestation
- Antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
- Actual or threatened pregnancy loss at any stage of gestation
- Ectopic pregnancy
1.2. Transfusion of Rh-incompatible blood or blood products
- Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates)
|
|
NEWS HIGHLIGHTS
Clinical Trials Related to Rhogam Ultra-Filtered Plus (Rho(d) Immune Globulin Human)
A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) [Completed]
To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a
threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the
safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in
subjects with chronic ITP for.
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage [Completed]
The investigators want to test whether infusions of intravenous immunoglobulin - a blood
product known to modify immune responses - in early pregnancy will increase the chance of a
subsequent live birth in women with three or more miscarriages after a birth and a total of
at least four miscarriages. This will be done in a trial where 82 patients will be randomly
allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.
Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis [Not yet recruiting]
This is a phase III multi-centre randomised, double blind, placebo controlled trial to
assess the role of intravenous immunoglobulin in the treatment of children with
encephalitis. The primary objective is to find out whether early use of IVIG treatment
improves neurological outcomes of children with encephalitis.
308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals
in the United Kingdom. Participants will be randomised to receive two doses of IVIG or
matching placebo in addition to other standard treatments, within the first five days of
hospital admission.
Each participant will be followed up for 12 months. During this period, information on
clinical, radiological and laboratory investigations will be collected. Neurological
outcomes will be assessed by the use of questionnaires at 6 and 12 months, and a
neuropsychological assessment at 12 months.
A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy [Recruiting]
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an
effective treatment for HIV associated myelopathy.
Intravenous Immunoglobulins in Complex-regional Pain Syndrome [Not yet recruiting]
The purpose of this study is to determine whether intravenous immunoglobulins are effective
in the treatment of complex-regional pain syndrome.
|
|
Page last updated: 2009-12-16
|