Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human anti-D immunoglobulin

Available from:

CSL Behring GmbH

ATC code:

J06BB; J06BB01

INN (International Name):

Human anti-D immunoglobulin

Dosage:

300 microgram(s)

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Specific immunoglobulins; anti-D (rh) immunoglobulin

Authorization status:

Marketed

Authorization date:

2003-10-17

Patient Information leaflet

Immunoglobulins have not been associated with hepatitis A or
parvovirus B19
infections, possibly because the antibodies against these infections,
which are
contained in the product, are protective.
It is strongly recommended that every time you receive a dose of
Rhophylac,
the name and batch number of the product are recorded in order to
maintain
a record of the batches used.
Blood tests
t
Tell your doctor or healthcare professional that you were treated with
Rhophylac if you or your new-born baby have any blood tests
(serological
testing).
After you were given this medicine, the results of some blood tests
may be
altered for a certain period of time. If you are a mother having
received this
medicine before delivery, the results of some blood tests in your
new-born
baby may also be affected.
OTHER MEDICINES AND RHOPHYLAC
t
Tell your doctor or healthcare professional if you are taking, have
recently
taken or might take any other medicines. This also applies to
medicines
obtained without a prescription.
Vaccinations
t
Tell your doctor or healthcare professional prior to treatment if you
have
just had a vaccination within the last 2 to 4 weeks. Also inform your
vaccinating doctor after the treatment. He or she can then plan to
check
the efficacy of your vaccination.
This medicine may impair the efficacy of vaccinations with live virus
vaccines,
for example against measles, mumps, rubella (German measles) or
varicella.
Such vaccinations should therefore not be given for 3 months after you
were
last given Rhophylac.
PREGNANCY AND BREAST-FEEDING
This medicinal product is used in pregnancy or early after delivery.
Immunoglobulins are excreted in human milk. In clinical studies, 432
mothers
received this medicine before delivery and 256 of them again after
delivery,
and no side effects were seen in their children.
DRIVING AND USING MACHINES
No effects of Rhophylac on the ability to drive and use machines are
expected.
RHOPHYLAC CONTAINS SODIUM
This medicine contains less than 1 mmol sodium (23 mg) per syringe,
that is
to

Summary of Product characteristics

Health Products Regulatory Authority
23 July 2020
CRN009W0M
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled
syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 300 micrograms (1500 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.
Distribution of the IgG subclasses (approximate values):
IgG
1
84.1 %
IgG
2
7.6 %
IgG
3
8.1 %
IgG
4
1.0%
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 the 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
Prevention of Rh(D) isoimmunisation in Rh(D) negative women

Antepartum prophylaxis
- Planned antepartum prophylaxis
- Antepartum prophylaxis following complications of pregnancy
including:
Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole,
intrauterine foetal death, transplacental haemorrhage
resulting from antepartum haemorrhage, amniocentesis, chorionic
biopsy, obstetric manipulative procedures e.g. external
version, invasive interventions, cordocentesis, blunt abdominal trauma
or foetal therapeutic intervention.

Postpartum prophylaxis
- Delivery of a Rh(D) positive (D, D
weak
, D
partial
) baby
An Rh(D) incompatible pregnancy is assumed if the foetus/baby is
either Rh(D) positive or Rh(D) unknown or if the father is
either Rh(D) positive or Rh(D) unkn