Rhophylac 300 solution for i/v and i/m injection

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

immunoglobulin anti-D (Rh) human

Prieinama:

CSL Behring AG

ATC kodas:

J06BB01

INN (Tarptautinis Pavadinimas):

immunoglobulin anti-D (Rh) human

Dozė:

300mcg/2ml

Vaisto forma:

solution for i/v and i/m injection

Vienetai pakuotėje:

pre-filled syringe 2ml and needle, in blister

Recepto tipas:

Prescription

Autorizacija statusas:

Registered

Leidimo data:

2020-12-31

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
RHOPHYLAC 300 MICROGRAMS / 2 ML, SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
Human anti-D immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or healthcare
professional.
-
If you get any side effects, talk to your doctor or healthcare
professional. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Rhophylac 300 is and what it is used for
2.
What you need to know before you are given Rhophylac 300
3.
How to use Rhophylac 300
4.
Possible side effects
5.
How to store Rhophylac 300
6.
Contents of the pack and other information
1.
WHAT RHOPHYLAC 300 IS AND WHAT IT IS USED FOR
WHAT RHOPHYLAC 300 IS
This medicine is a ready-to-use solution for injection, which comes in
a pre-filled syringe. The solution
contains special proteins, isolated from human blood plasma. These
proteins belong to the class of
“immunoglobulins”, also called antibodies. The active ingredient
of Rhophylac 300 is a specific antibody
called “anti-D (Rh) immunoglobulin”. This antibody works against
Rhesus factor type D.
WHAT RHESUS FACTOR TYPE D IS
Rhesus factors are special characteristics of human red blood cells.
About 85 % of the population carry the
so called Rhesus factor type D (abbreviated “Rh(D)”). These people
are called _Rh(D) positive_. People who
do not carry Rhesus factor type D are called _Rh(D) negative_.
WHAT ANTI-D (RH) IMMUNOGLOBULIN IS
Anti-D (Rh) immunoglobulin is an antibody, which works against Rhesus
factor type D and is produced by
the human immune system. When a Rh(D) negative person receives Rh(D)
positive blood, her/his immune
system will recognise the Rh(D) positive red blood cells as
“foreign” to her/his body, and will attempt to
destroy them. For this purpose, the immune system will build specific
antibodies agai

Prekės savybės

_((This page is for administrative data only, its contents will not
appear on the printed packaging item. _
_Equally, notes –displayed as italic text in double brackets–, as
well as _
_headers, footers, line numbers and text in grey boxes on all other
pages will not be printed.)) _
1
COMMON EU PRODUCT INFORMATION– EU-PI (ENGLISH / EN)
RHOPHYLAC
® 300 MICROGRAMS / 2 ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
REV.: 25-JUN-2019 / 2
ND RESPONSE
Supersedes previous version(s)
Rev.: 20-May-2019 / Response to NWG
Rev.: 14-JAN-2019 / CCDS V2.0 update (Addition of dose recommendation
summary and editorial
amendments
2
SUMMARY OF PRODUCT CHARACTERISTICS
3
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 immunoglobulin 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 abort