D-GAM 50MCG/ML SOLUTION FOR INJECTION
País: Chipre
Língua: grego
Origem: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
Folheto informativo - Bula
(PIL)
28-06-2020
Características técnicas
(SPC)
15-03-2018
Ingredientes ativos:
ANTI-D IMMUNGLOBULIN
Disponível em:
BPL BIOPRODUCTS LABORATORY GMBH (0000011488) DORNHOFSTRASSE 34, NEU-ISENBURG, 63263
Código ATC:
J06BB01
DCI (Denominação Comum Internacional):
ANTI-D (RH) IMMUNOGLOBULIN
Dosagem:
50MCG/ML
Forma farmacêutica:
SOLUTION FOR INJECTION
Composição:
ANTI-D IMMUNGLOBULIN (8000031029) 500IU
Via de administração:
INTRAMUSCULAR USE
Tipo de prescrição:
Εθνική Διαδικασία
Área terapêutica:
ANTI-D (RH) IMMUNOGLOBULIN
Resumo do produto:
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 2ML (500 IU) (230009401) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
Folheto informativo - Bula
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Características técnicas
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
D-GAM ®, HUMAN ANTI-D IMMUNOGLOBULIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Anti-D Immunoglobulin Ph.Eur.*
Each vial contains: 5 - 50 g/L protein (250 and 500 IU vials) or 20 -
180 g/L protein (1,500 and 2,500
IU vials) of which at least 95% is gammaglobulin (IgG). The product
contains less than 0.02% w/w of
IgA.
The correct volume to give the stated potency is overprinted on the
label. The product is prepared from
plasma from RhD-negative screened donors who have been immunised
against RhD antigen and
contains specific antibodies against erythrocyte RhD antigen. Donors
are selected from the USA.
The product is presented in three different concentrations but the
highest concentration is filled in
different volumes to achieve two dose presentations. The product is
therefore available in four nominal
doses, namely 250 IU per vial, 500 IU per vial, 1,500 IU per vial and
2,500 IU per vial.
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 incompatible transfusions of
RhD positive blood or other
products containing red blood cells (e.g. platelets).
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 g
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