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 Limited

ATC code:

J06BB01

INN (International Name):

ANTI-D IMMUNOGLOBULIN

Dosage:

625 IU/ML

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

Specific immunoglobulins

Authorization status:

Authorised

Authorization date:

2006-04-28

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 (miscarri

Summary of Product characteristics

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 µg)
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 µg) of human anti-D immunoglobulin
One ampoule of 2 ml contains 1250 IU (250 µg) of human anti-D immunoglobulin
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 WOMEN.
ANTENATAL PROPHYLAXIS
•
Planned antenatal prophylaxis
•
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
Pregnancy/delivery of a Rh(D) positive (D, D
weak
, D
partial
) baby
TREATMENT OF RH(D) NEGATIVE PERSONS AFTER INCOMPATIBLE TRANSFUSIONS OF RH(D) POSITIVE BLOOD OR OTHER PRODUCTS
CONTAINING RED BLOOD CELLS E.G. PLATELET CONCENTRATE.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 21/09/2015_
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dose o