Immunorho Dosage/Direction for Use

Posology: The dose of anti-D immunoglobulin should be determined according to the level of exposure to Rh(D) positive red blood cells and considering that 0.5 ml of packed Rh(D) positive red blood cells or 1 ml of Rh(D) positive blood is neutralised by approximately 10 micrograms (50 IU) of anti-D immunoglobulin.
Consideration should also be given to dose and dose schedule for human anti-D immunoglobulin for intramuscular use recommended in other official or Member States guidance.
Prevention of Rhesus sensitization, Rhesus induced morbus haemolyticus neonatorum in Rh(-) pregnancy which pregnant with Rh(+) husband: Antenatal prophylaxis: According to general recommendations, currently administered doses range from 50-330 micrograms or 250-1650 IU.
Planned antenatal prophylaxis: A single dose at 28-30 weeks of gestation or two doses at 28 and 34 weeks.
Antenatal prophylaxis following complications of pregnancy: A single dose should be administered as soon as possible and within 72 hours and if necessary repeated at 6-12 week intervals throughout the pregnancy.
Postnatal prophylaxis: According to general recommendations, currently administered doses range from 100 to 300 micrograms or 500 to 1500 IU. If the lower dose (100 micrograms or 500 IU) is administered, a test should be performed to determine the extent of fetal-maternal haemorrhage.
For postnatal use, the product should be administered to the mother as soon as possible within 72 hours of delivery of an Rh positive (D, D^weak, D^partial) infant. If more than 72 hours have elapsed, the product should not be withheld but administered as soon as possible.
The postnatal dose must still be given even when antenatal prophylaxis has been administered and even if residual activity from antenatal prophylaxis can be demonstrated in maternal serum.
If a large feto-maternal haemorrhage [>4 mL (0.7%-0.8% of women)] is suspected, e.g. in the event of fetal/neonatal anaemia or intrauterine fetal death, its extent should be determined by a suitable method e.g. Kleihauer-Betke acid elution test to detect fetal HbF (fetal hemoglobin) or flow cytometry which specifically identifies Rh(D) positive cells. Additional doses of anti-D immunoglobulin should be administered accordingly (10 micrograms or 50 IU per 0.5 ml fetal red blood cells).
The use of an alternative intravenous product is recommended as it allows to achieve adequate plasma levels immediately. If no intravenous product is available, a very high dose should be administered intramuscularly for a period of several days (see Precautions).
Paediatric population: The safety and efficacy of IMMUNORHO in children have not been established. The appropriate dosage should be calculated with the advice of a specialist in transfusion medicine.
Method of administration: Intramuscular use: If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer the medicine in divided doses at different sites.
If intramuscular administration is contraindicated (bleeding disorders), an alternative intravenous product should be used.
Overweight patients: In case of overweight/obese patients the use of an intravenous anti-D product must be considered (see Precautions).
For instruction before administration, see Special precautions for disposal and handling under Cautions for Usage.