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:

2015-12-30

Pakuotės lapelis

OBESITY
There have been reports that the intramuscular administration of
Rhophylac
in patients with a body mass index (BMI)
³
30 is associated with a risk of
lack
of
efficacy. Therefore,
in
patients
with
a
BMI
³
30
intravenous
administration should be considered.
INFORMATION ON SAFETY WITH RESPECT TO TRANSMISSIBLE AGENTS
Standard measures to prevent infections resulting from the use of
medicinal
products prepared from human blood or plasma include selection of
donors,
screening of individual donations and plasma pools for specific
markers of
infection
and
the
inclusion
of
effective
manufacturing
steps
for
the
inactivation/removal of viruses. Despite this, when medicinal products
prepared from human blood or plasma are administered, the possibility
of
transmitting infective agents cannot be totally excluded. This also
applies to
unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such
as
human immunodeficiency virus (HIV), hepatitis B virus (HBV) and
hepatitis
C virus (HCV). They may be of limited value against non-enveloped
viruses
such as hepatitis A (HAV) or parvovirus B19.
There is reassuring clinical experience regarding the lack of
hepatitis A or
parvovirus B19 transmission with immunoglobulins and it is also
assumed
that the antibody content makes an important contribution to the viral
safety.
It is strongly recommended that every time that Rhophylac is
administered
to a patient, the name and batch number of the product are recorded in
order to maintain a link between the patient and the batch of the
product.
8.
INTERACTION
LIVE ATTENUATED VIRUS VACCINES
Active immunisation with live virus vaccines (e.g. measles, mumps,
rubella
or
varicella)
should
be
postponed
until
3
months
after
the
last
administration of anti-D immunoglobulin, as the efficacy of the live
virus
vaccine
may
be
impaired.
If
anti-D
immunoglobulin
needs
to
be
administered within 2 to 4 weeks of a live virus vaccination, then the
efficacy of such a vaccination may be impaired.
I

Prekės savybės

CSL BEHRING LATAM/EEMEA RPI
ROPHYLAC, 300: HUMAN ANTI-D IMMUNOGLOBULIN
VERSION 1.0 REVISION DATE 08-10-2015
RHOPHYLAC 300 MICROGRAMS / 2 ML, CSL Behring AG
Page 1 of 14
REGIONAL PRODUCT INFORMATION
(LATAM/EEMEA)
ENGLISH
RHOPHYLAC, 300
HUMAN ANTI-D IMMUNOGLOBULIN
VERSION: 1.0
REVISION DATE: 08-10-2015
REASON FOR CHANGE: CCSI V2.0 UPDATE AND NEW RPI TEMPLATE
IMPLEMENTATION
Text Convention:
Headers, footers and line numbers will not be printed.
text:
text to be adapted as appropriate, according to local requirements
CSL BEHRING LATAM/EEMEA RPI
ROPHYLAC, 300: HUMAN ANTI-D IMMUNOGLOBULIN
VERSION 1.0 REVISION DATE 08-10-2015
RHOPHYLAC 300 MICROGRAMS / 2 ML, CSL Behring AG
Page 2 of 14
CSL BEHRING
1
2
1.
NAME OF THE MEDICINAL PRODUCT
3
Rhophylac 300
4
5
6
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
7
8
_a._
_ _
_Active substance _
9
Human Anti-D immunoglobulin*.
10
The product contains a maximum of 30 mg/ml of human plasma proteins of
which 10 mg/ml is
11
human albumin as stabiliser. At least 95% of the other plasma proteins
are IgG. Distribution of the
12
IgG subclasses (approximate values): IgG1 84.1 %, IgG2 7.6 %, IgG3 8.1
%, IgG4 1.0 %.
13
Rhophylac contains not more than 5 micrograms/ml IgA.
14
15
*Produced from the plasma of human donors.
16
17
18
_b._
_ _
_Excipients _
19
Human albumin
10 mg/ml
20
Glycine
20.6 mg/ml
21
Sodium chloride
≤ 250 mmol/l
22
23
Rhophylac contains no preservatives.
24
25
3.
PHARMACEUTICAL FORM AND UNIT CONTENT OF ACTIVE INGREDIENT
26
Solution for intravenous or intramuscular injection in a pre-filled
syringe.
27
Each 2 ml solution in a pre-filled syringe contains:
28
Human anti-D immunoglobulin G (IgG) 1,500 IU (300 micrograms)
corresponding to a
29
concentration of 750 IU (150 micrograms) per ml.
30
CSL BEHRING LATAM/EEMEA RPI
ROPHYLAC, 300: HUMAN ANTI-D IMMUNOGLOBULIN
VERSION 1.0 REVISION DATE 08-10-2015
RHOPHYLAC 300 MICROGRAMS / 2 ML, CSL Behring AG
Page 3 of 14
31
Rhophylac is a clear, colourless to pale yellow immunoglobulin
solution.
32
The solution is slightly hypertonic. Rhophy