Inclusion on the list of medicines approved for hospital use.
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Clinical Benefit
Insufficient
In view of the fact that the product can only be given by intramuscular injection and in the light of the dose levels available, the actual benefit of RHESONATIV 625 IU/ml is insufficient in the following situations : - Prevention of RhD immunisation in RhD-negative women : o as planned antenatal prophylaxis in the third trimester of pregnancy ; o as antenatal prophylaxis following complications of pregnancy in the second or third trimester with established foetomaternal haemorrhage (Kleihauer test result positive) ; o as post-natal prophylaxis after delivery of an RhD. - positive baby with established foetomaternal haemorrhage (Kleihauer test result po sitive) ; - In the treatment of RhD-negative individuals who have had an incompatible transfusion of RhD positive blood or other products containing red blood cells, such as platelet concentrates.
Substantial
The actual benefit of RHESONATIV 625 IU/ml is substantial in the following situations : - Prevention of RhD immunisation in RhD-negative women : o as antenatal prophylaxis where a risk factor for foetomaternal haemorrhage in the first trimester of pregnancy is present ; o as antenatal prophylaxis where a risk factor for foetomaternal haemorrhage is present in the second or third trimester of pregnancy when the Kleihauer test result is negative ; o as post-natal prophylaxis after delivery of an RhD - positive baby when the Kleihauer test result is negative.
Clinical Added Value
no clinical added value
RHESONATIV 625 IU/ml provides no improvement in actual benefit (IAB V) compared to RHOPHYLAC.
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