RHOPHYLAC 300

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ANTI-D IMMUNOGLOBULINS

Available from:

CSL BEHRING LTD., ISRAEL

ATC code:

J06BB01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ANTI-D IMMUNOGLOBULINS 150 MCG/ML

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

CSL BEHRING AG, SWITZERLAND

Therapeutic group:

ANTI-D (RH) IMMUNOGLOBULIN

Therapeutic area:

ANTI-D (RH) IMMUNOGLOBULIN

Therapeutic indications:

Prophylaxis of Rh (D) immunisation in Rh (D)-negative women: Anti-D immune globulin is administered for the prevention of Rh (D) immunization if it has been demonstrated or if it is suspected that fetal erythrocytes have entered the circulation of the mother. Treatment is not necessary when it is assured that the child or the father are Rh (D)- negative. Criteria for a rhesus-incompatible pregnancy and the administration of anti-D immune globulin are : a) the mother is Rh (D) -negative b) the child is either Rh (D)-positive Rh (D)weak - positive or its rhesus type is not known. Routine antepartum prophylaxis : To prevent Rh (D) immunisation due to spontaneous fetomaternal haemorrhage (FMH) during the last trimester of pregnancy. Postpartum prophylaxis To prevent Rh (D) immunisation of the Rh (D)-negative mother following delivery of a Rh (D)-positive child. Complications of pregnancy: Interventions during pregnancy such as invasive prenatal diagnosis (e.g. amniocentesis chorionic villus sampling fetal blood sampling) or other intrauterine procedures (e.g. insertion of shunts embryo reduction) external version of the fetus and therapeutic abortion. Incidents during pregnancy such as antepartum haemorrhage spontaneous abortion ruptured tubal pregnancy ectopic pregnancy stillbirths intrauterine death and abdominal trauma. Treatment of Rh (D) -negative persons after incompatible transfusions of Rh (D)-positive blood or erythrocyte concentrate: Prevention of Rh (D) immunisation in Rh (D)-negative persons who for any reason have been given blood or blood components containing Rh (D)-positive red cells.

Authorization date:

2023-02-28

Summary of Product characteristics

RHOPHYLAC
®
300
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
RHOPHYLAC 300
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml solution in pre-filled syringe contains 300 micrograms
(1,500 IU) human anti-D
immunoglobulin*.
One ml contains 150 micrograms (750 IU) human anti-D immunoglobulin .
The product contains a maximum of 30 mg/ml of human plasma proteins of
which 10 mg/ml
is human albumin as stabiliser. At least 95% of the other plasma
proteins are IgG.
The content of immunoglobin A (IgA) is not more than 5 micrograms/ml.
*Produced from the plasma of human donors.
Excipient with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per syringe,
that is to say essentially
“sodium
-free".
Rhophylac contains no preservatives.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear or slightly opalescent and colourless or pale
yellow.
Rhophylac has an osmolality of at least 240 mosmol/kg.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of Rh (D) immunisation in Rh (D)-negative women:
Anti-D immune globulin is administered for the prevention of Rh (D)
immunization if it has
been demonstrated, or if it is suspected, that fetal erythrocytes have
entered the circulation of
the mother. Treatment is not necessary when it is assured that the
child or the father are Rh
(D)-negative. Criteria for a rhesus-incompatible pregnancy and the
administration of anti-D
immune globulin are: a) the mother is Rh (D)-negative; b) the child is
either Rh (D)-positive,
Rh (D) weak - positive or its rhesus type is not known.
Routine antepartum prophylaxis: To prevent Rh (D) immunisation due to
spontaneous fetomaternal
haemorrhage (FMH) during the last trimester of pregnancy.
Postpartum prophylaxis: To prevent Rh (D) immunisation of the Rh
(D)-negative mother
following delivery of a Rh (D)-positive child.
Complications of pregnancy: Interventions during pregnancy, such as
invasive prenatal diagnosis
(e.g. amniocentesis, chorionic vi