D-Gam Human Anti-D Immunoglobulin
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
08-05-2024
Summary of Product characteristics
(SPC)
08-05-2024
Active ingredient:
ANTI, D IMMUNOGLOBULIN, HUMAN
Available from:
Bio Products Laboratory Limited
ATC code:
J06BB01
INN (International Name):
ANTI, D IMMUNOGLOBULIN, HUMAN
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
ANTI-D IMMUNOGLOBULIN, HUMAN 250 international unit(s)/millilitre
Prescription type:
POM
Therapeutic area:
IMMUNE SERA AND IMMUNOGLOBULINS
Authorization status:
Authorised
Authorization date:
2008-01-28
Patient Information leaflet
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Summary of Product characteristics
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
D-GAM
®
, Human Anti-D Immunoglobulin, 250 IU, solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 IU human Anti-D immunoglobulin
One ml contains 125 IU/mL human Anti-D immunoglobulin.
*100 micrograms of human anti-D immunoglobulin correspond to 500 international units
(IU).
Human protein content 5 – 50 g/L of which at least 95% is IgG.
For excipients see 6.1.
3.
PHARMACEUTICAL FORM
A solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of RhD immunisation in RhD negative women:
i.
Pregnancy/delivery of a RhD positive baby.
ii.
Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole.
iii.
After ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy or obstetric
manipulative procedure e.g. external version, or abdominal trauma, which may cause
transplacental haemorrhage (TPH).
Treatment of RhD negative patients after transfusions of RhD positive blood or other
products containing RhD positive red blood cells (e.g. platelets).
Page 2 of 5
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
a)
Post-Natal Dosage:
The recommended dose is 500 IU.
For postnatal use, the product should be administered as soon as possible within 72
hours of delivery.
If a large fetomaternal haemorrhage is suspected, its extent should be determined by
a suitable method and additional doses of anti-D should be administered as indicated.
b)
Ante-Natal Prophylaxis:
500 IU given at both 28 and 34 weeks of gestation or
a single dose of 1,500 IU at 28 weeks of gestation.
c)
Following
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