Rhesonativ Solution for Injection 625IU/ml (1ml amp)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ANTI, D IMMUNOGLOBULIN, HUMAN

Available from:

Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium

ATC code:

J06BB01

INN (International Name):

ANTI-D IMMUNOGLOBULIN, HUMAN 625 IU/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ANTI-D IMMUNOGLOBULIN, HUMAN 625 IU/ml

Prescription type:

POM

Therapeutic area:

IMMUNE SERA AND IMMUNOGLOBULINS

Authorization status:

Authorised

Authorization date:

2010-04-21

Patient Information leaflet

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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 as drawing of amniotic flui

Summary of Product characteristics

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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
µ
g)
Human protein content
165 mg
thereof 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
µ
g) of human anti-D immunoglobulin.
One ampoule of 2 ml contains 1250 IU (250
µ
g) 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
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procedures e.g. external version, invasive interventions,
cordocentesis, blunt
abdominal trauma or fetal therapeutic intervention.
•
POSTNATAL PROPHYLAXIS
o
Delivery of a Rh(D) positive (D, D
weak
, D
partial
) baby
TREATMENT OF RH(D) NEGATIVE CHILDBEARING AGE WOMEN AFTER INCOMPATIBLE
TRANSFUSIONS OF
RH(D) POSITIVE BLOOD OR OTHER PRODUCTS CONTAINING RED BLOOD C