Rh(D) Immunoglobulin-VF

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Anti-D [Rho] immunoglobulin 250 [iU]

Available from:

CSL Behring (NZ) Ltd

INN (International Name):

Anti-D [Rho] immunoglobulin 250 IU

Dosage:

250 IU

Pharmaceutical form:

Solution for injection

Composition:

Active: Anti-D [Rho] immunoglobulin 250 [iU]

Units in package:

Vial, glass, 250 IU

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

CSL Behring (Australia) Pty Ltd

Therapeutic indications:

Rh(D) Immunoglobulin-VF is indicated for the prevention of Rh sensitisation in Rh(D) negative females at or below child bearing age.

Product summary:

Package - Contents - Shelf Life: Vial, glass, - 250 IU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1998-05-28

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Rh(D) Immunoglobulin-VF NZ DS 16.00
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1 PRODUCT NAME
Rh(D) Immunoglobulin-VF 250 IU, solution for intramuscular injection
Rh(D) Immunoglobulin-VF 625 IU, solution for intramuscular injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human anti-D (Rh
o
) immunoglobulin
Rh(D) Immunoglobulin-VF is a sterile solution containing human plasma
protein of which at least
98% is immunoglobulin (mainly IgG), with an anti-D (Rh
o
) antibody content of 625 IU per vial/
≥10 mg/mL human plasma proteins or 250 IU per vial/ ≥10 mg/mL
human plasma proteins.
Rh(D) Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A
(IgA).
Rh(D) Immunoglobulin-VF is manufactured from human plasma donated by
voluntary donors.
Rh(D) Immunoglobulin-VF contains 22.5 mg/mL glycine.
Rh(D) Immunoglobulin-VF contains no preservatives.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The pH value of the ready-to-use solution is 6.6.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rh(D) Immunoglobulin-VF is indicated for the prevention of Rh
sensitisation in Rh(D) negative
females at or below child bearing age.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
SENSITISING EVENTS IN PREGNANCY (UNLESS THE BLOOD TYPE OF THE FOETUS
IS CONFIRMED TO BE RH(D)
NEGATIVE
The recommended dose of anti-D immunoglobulin is:
•
250 IU after sensitising events in the first trimester of pregnancy
and
•
625 IU after sensitising events beyond the first trimester.
If the gestational age is not known with certainty and the possibility
exists that the gestational age is
13 weeks or more, 625 IU should be given.
NEW ZEALAND DATA SHEET
Rh(D) Immunoglobulin-VF NZ DS 16.00
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In twin and multiple pregnancies in the first trimester, 625 IU should
be given.
The dose should be given as soon as possible and within 72 hours of
the event.
Sensitising events include normal delivery, miscarriage, termination
of pregnancy, ectopic pregnancy,
chorionic villus sampling, amniocentesis, cordoce