Human Anti-D Immunoglobulin 300mcg (1500IU)

NAME OF THE MEDICINE

Immunorho

Human Anti-D Immunoglobulin 300 mcg (1500 IU) Powder and solvent for solution for injection for intramuscular use 

COMPOSITION

Human anti-D immunoglobulin

Each 2 ml vial contains respectively 1000* IU or 1500* IU human anti-D immunoglobulin according to the pack size.

Each 2 ml pre-filled syringe contains 1500* IU human anti-D immunoglobulin.

*100 micrograms of human anti-D immunoglobulin correspond to 500 International Units (IU).

1 ml of solution for injection after reconstitution of the freeze-dried product with the solvent vial contains:

1 ml of solution for injection in pre-filled syringe contains:

The maximum content of IgA is 0.3 mg/ml

Excipients:

The product contains 3.9 mg of sodium per ml

INDICATIONS

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

• Antenatal prophylaxis
• Planned antenatal prophylaxis
• Antenatal prophylaxis following complications of pregnancy including:

Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole, intrauterine fetal death, transplacental haemorrhage resulting from ante-partum haemorrhage,  amniocentesis,  chorionic  biopsy,  obstetric  manipulative procedures e.g. external version, invasive interventions, cordocentesis, blunt abdominal trauma or fetal therapeutic intervention.

• Postnatal prophylaxis

Delivery of a Rh(D) positive (D, Dweak, Dpartial) baby

• Treatment of Rh(D) negative persons after incompatible transfusions of Rh(D) positive blood or other products containing red blood cells e.g. platelet concentrate.

PRESENTATION

IMMUNORHO 300 micrograms (1500 IU):

Type I glass vial containing 300 micrograms of powder; Type I glass vial containing 2 ml of solvent;

2 ml of solution in pre-filled syringe (type I glass), with a plunger made of rubber (halobutyl) and attached needle.

MANUFACTURER

Kedrion S.p.A

Bolognana Gallicano – 55027 Lucca – Italy

Read the package insert carefully before use.

For any more information, please consult your doctor