RHESONATIV Solution for injection Ref.[49912] Active ingredients: Anti-D (rh) immunoglobulin

Posology

The dose of anti-D immunoglobulin should be determined according to the level of exposure to Rh(D) positive red blood cells and based on the knowledge 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. The following doses are recommended based on the clinical studies performed with Rhesonativ.

Prevention of Rh(D) immunisation in Rh(D) negative women

• Antenatal prophylaxis. According to general recommendations, currently administered doses range from 50–330 micrograms or 250-1650 IU.
• Planned antenatal prophylaxi: A single dose (e.g. 250 micrograms or 1250 IU) at 28-30 weeks of gestation or two doses at 28 and 34 weeks.
• Antenatal prophylaxis following complications of pregnancy: A single dose (e.g. 125 micrograms or 625 IU before the 12th week of pregnancy) (e.g. 250 micrograms or 1250 IU after the 12th week of pregnancy) should be administered as soon as possible and within 72 hours and if necessary repeated at 6–12 week intervals throughout the pregnancy. After amniocentesis and chorionic biopsy a single dose (e.g. 250 micrograms or 1250 IU) should be administered.
• Postnatal prophylaxis. According to general recommendations, currently administered doses range from 100–300 micrograms or 500–1500 IU. For specific study details see section 5.1. If the lower dose (100 micrograms or 500 IU) is administered then testing of the amount of fetal maternal haemorrhage should be performed.

Standard dose: 1250 IU (250 micrograms).

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 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.

Incompatible transfusions of red blood cells (RBCs)

The recommended dose is 20 micrograms (100 IU) anti-D immunoglobulin per 2ml of transfused Rh (D) positive blood or per 1 ml of RBC concentrate. It is recommended the consultation with a specialist in transfusion medicine in order to evaluate the feasibility of a red cell exchange procedure to reduce the load of D positive red cells in circulation and to define dose of anti-D immunoglobulin required to suppress immunisation. Follow-up tests for D positive red cells should be undertaken every 48 hours and further anti-D given until there are no detectable D positive red cells in circulation. In any case, due to possible risk of haemolysis it is suggested to not exceed a maximum dose of 3000 micrograms (15000 IU).

The use of an alternative intravenous product is recommended as it will achieve adequate plasma levels immediately. If no intravenous product is available, the very large volume should be administered intramuscularly over a period of several days (see section 4.4).

Paediatric population

The safety and efficacy in children has not yet been established.

Overweight patients

In case of overweight/obese patients the use of an intravenous anti-D product should be considered (see section 4.4).

Method of administration

Intramuscular use.

If large total doses (>2 ml for children or >5 ml for adults) are required, it is advisable to administer them in divided doses at different injection sites.

If intramuscular administration is contraindicated (bleeding disorders), an alternative intravenous product should be used. The injection can be administered subcutaneously if no intravenous product is available. Careful manual pressure with a compress should be applied to the site after injection.

Consequences of an overdose are not known. Patients in receipt of incompatible transfusion, who receive very large doses anti-D immunoglobulin, should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction. In other Rh(D) negative individuals, overdosage should not lead to more frequent or more severe undesirable effects than the normal dose.

30 months.

The content of an opened ampoule should be used immediately.

Store in a refrigerator (2°C-8°C). Do not freeze.

Keep the ampoule in the outer carton in order to protect from light.

Within its shelf-life, the product may be stored below 25°C for up to 1 month, without being refrigerated again during this period, and must be discarded if not used after this.

For storage conditions after first opening of the medicinal product, see section 6.3.

1 ml and 2 ml of solution in an ampoule (type I glass).

Pack sizes: 1x1 ml, 1x2 ml and 10x2 ml.

Not all pack sizes may be marketed.

The product should be brought to room or body temperature before use.

The colour can vary from colourless to pale-yellow up to light-brown. Do not use solutions that are cloudy or have deposits.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.