Rhesonativ 625 IU/ml, solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Anti-d immunoglobulin

Available from:

Octapharma (IP) SPRL

ATC code:

J06BB; J06BB01

INN (International Name):

Anti-d immunoglobulin

Dosage:

625 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Specific immunoglobulins; anti-D (rh) immunoglobulin

Authorization status:

Not marketed

Authorization date:

2006-04-28

Patient Information leaflet

_20210311_pil_870_IE_15.14_en _
_1/6 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
RHESONATIV 625 IU/ML, SOLUTION FOR INJECTION
Human anti-D immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rhesonativ is and what it is used for
2.
What you need to know before you use Rhesonativ
3.
How to use Rhesonativ
4.
Possible side effects
5.
How to store Rhesonativ
6.
Contents of the pack and other information
1
WHAT RHESONATIV IS AND WHAT IT IS USED FOR
Rhesonativ is an immunoglobulin and contains antibodies to the Rhesus
factor. If a woman
who lacks the Rhesus factor in her red blood cells (=Rh-negative) is
pregnant with an
unborn baby which has the Rhesus factor (=Rh-positive), her immune
defence system may
be stimulated to form antibodies to the Rhesus factor. These
antibodies may harm her
unborn baby, especially in subsequent pregnancies.
Rhesonativ is used to keep the Rh-negative woman from becoming
immunised in the
course of pregnancy and childbirth, and in this way prevent harm to
the unborn baby.
Rhesonativ is used in Rh-negative woman in case of:

Anti-D prevention therapy for pregnant women who are Rh- negative

Delivery of a Rh-positive baby

Abortion/threatened abortion (miscarriage/threatened miscarriage)

Pregnancy outside the uterus, certain growths inside the uterus
(mole), or bleeding of
blood of the unborn baby into the normally separated maternal
circulation or death of
the unborn baby late in pregnancy

Invasive procedures during pregnancy such

Summary of Product characteristics

Health Products Regulatory Authority
09 June 2021
CRN00C137
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rhesonativ 625 IU/ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human anti-D immunoglobulin.
1 ml contains:
Human anti-D immunoglobulin 625 IU (125 micrograms)
Human protein content: 165 mg
there of immunoglobulin G, at least 95%
The content of IgA does not exceed 0.05% of the total protein content.
One ampoule of 1 ml contains 625 IU (125 micrograms) of human anti-D
immunoglobulin.
One ampoule of 2 ml contains 1250 IU (250 micrograms) of human anti-D
immunoglobulin.
The potency is determined using the European Pharmacopoeia assay. The
equivalence in International Units of the
International Reference Preparation is stated by the World Health
Organization.
Distribution of the IgG subclasses (approx. values):
IgG1 ............. 70.5%
IgG2 ............. 26.0%
IgG3 ............. 2.8%
IgG4 ............. 0,8%
The maximum IgA content is 82.5 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The colour of the solution can vary from colourless to pale-yellow up
to light brown.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PREVENTION OF RH(D) IMMUNISATION IN RH(D) NEGATIVE CHILDBEARING AGE
WOMEN.

ANTENATAL PROPHYLAXIS
o
Planned antenatal prophylaxis
o
Antenatal prophylaxis following complications of pregnancy including
Abortion/threatened abortion, ectopic
pregnancy or hydatidiform mole, intrauterine fetal death (IUFD),
transplacental haemorrhage (TPH) resulting
from ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy,
obstetric manipulative procedures, e.g.
external version, invasive interventions, cordocentesis, blunt
abdominal trauma or fetal therapeutic
intervention.

POSTNATAL PROPHYLAXIS
Health Products Regulatory Authority
09 June 2021
CRN00C137
Page 2 of 8
o
Delivery of a Rh(D) positive (D, D
weak
, D
partial
) baby
TREATMENT OF RH