Rhesonativ 625IU/ml solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

human anti-D immunoglobulin

Available from:

Octapharma AB

ATC code:

J06BB01

INN (International Name):

human anti-D immunoglobulin

Dosage:

625IU/ml

Pharmaceutical form:

solution for injection

Units in package:

(1) ampoule 1ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-08-23

Patient Information leaflet

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
fluid
with a syringe (i.e. amniocentesis), or blood sampling of the unborn
baby
from the umbilical vein, biopsy or obstetric manipulative procedures,
e.g.
procedures to manually rotate the baby to a correct position in the
uterus,
or belly trauma, surgical treatment of the unborn baby inside the
uterus
Rhesonativ may also be used in Rh-negative individuals who have
accidentally
received an Rh-positive blood transfusion.
WHAT RHESONATIV LOOKS LIKE AND CONTENTS OF THE PACK
Rhesonativ is a solution for injection (625 IU/ml or 1250 IU/2 ml per
ampoule).
Pack sizes: 1x1 ml, 1x2 ml and 10x2 ml.
The colour of the solution can vary from colourless to pale-yellow up
to light-
brown.
Not all pack sizes may be marketed.
MANUFACTURER
Octapharma AB
SE-112 75 Stockholm
Sweden
THIS LEAFLET WAS LAST REVISED IN 03/2014.
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THE FOLLOWING INFO

Summary of Product characteristics

ocf

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