HyperRAB Solution for Infiltration & Intramuscular Injection

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

RABIES IMMUNE GLOBULIN (HUMAN)

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

J06BB05

Dosage:

150 iu/ml

Pharmaceutical form:

INJECTION

Composition:

RABIES IMMUNE GLOBULIN (HUMAN) 150 iu/ml

Administration route:

INTRAMUSCULAR, INFILTRATION

Prescription type:

Prescription Only

Manufactured by:

Grifols Therapeutics LLC

Authorization status:

ACTIVE

Authorization date:

1998-02-26

Patient Information leaflet

5 WARNINGS AND PRECAUTIONS
5.1 HYPERSENSITIVITY REACTIONS
Severe
hypersensitivity
reactions
may
occur
with
HYPERRAB.
Patients with a history of prior systemic allergic reactions to human
immunoglobulin preparations are at a greater risk of developing
severe hypersensitivity and anaphylactic reactions. Have epinephrine
available for treatment of acute allergic symptoms, should they
occur.
Patients with isolated immunoglobulin A (IgA) deficiency may
develop
severe
hypersensitivity
reactions
to
HYPERRAB,
or
subsequently, to the administration of blood products that contain
IgA.
5.2 TRANSMISSIBLE INFECTIOUS AGENTS
HYPERRAB is made from human blood and may carry a risk of
transmitting infectious agents, e.g., viruses, the variant
Creutzfeldt-
Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob
disease (CJD) agent. HYPERRAB is purified from human plasma
obtained from healthy donors. When medicinal biological products
are
administered,
infectious
diseases
due
to
transmission
of
pathogens cannot be totally excluded. However, in the case of
products prepared from human plasma, the risk of transmission of
pathogens is reduced by: (1) epidemiological controls on the donor
population and selection of individual donors by a medical interview
and screening of individual donations and plasma pools for viral
infection markers; (2) testing of plasma for hepatitis C virus (HCV),
human immunodeficiency virus (HIV), hepatitis B virus (HBV), HAV
and human parvovirus (B19V) genomic material; and (3) manufac-
turing procedures with demonstrated capacity to inactivate/remove
pathogens.
ALL infections thought by a physician possibly to have been
transmitted by this product should be reported by the physician or
other healthcare provider to Grifols Therapeutics LLC [1-800-520-
2807].
6 ADVERSE REACTIONS
The most common adverse reactions in >5% of subjects during
clinical trials were injection site pain, headache, injection site
nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and
oropharyngeal pain.
6.1 CL

Summary of Product characteristics

and selection of individual donors by a medical interview and
screening of
individual donations and plasma pools for viral infection markers; (2)
testing of
plasma for hepatitis C virus (HCV), human immunodeficiency virus
(HIV),
hepatitis B virus (HBV), HAV and human parvovirus (B19V) genomic
material;
and
(3)
manufacturing
procedures
with
demonstrated
capacity
to
inactivate/remove pathogens.
ALL infections thought by a physician possibly to have been
transmitted by this
product should be reported by the physician or other healthcare
provider to
Grifols Therapeutics LLC [1-800-520-2807].
6 ADVERSE REACTIONS
The most common adverse reactions in >5% of subjects during clinical
trials
were injection site pain, headache, injection site nodule, abdominal
pain,
diarrhea, flatulence, nasal congestion, and oropharyngeal pain.
6.1 CLINICAL TRIALS EXPERIENCE
Because clinical trials are conducted under widely varying conditions,
adverse
reaction rates observed in the clinical trials of a drug cannot be
directly
compared to rates in the clinical trials of another drug and may not
reflect the
rates observed in practice.
The
new
formulation
for
HYPERRAB
is
manufactured
using
caprylate/
chromatography purification and has a rabies antibody concentration of
300 IU/mL. The previous formulation, HYPERRAB S/D, was manufactured
using a solvent detergent process and had a rabies antibody
concentration of
150 IU/mL. These products were evaluated in 2 clinical trials in a
total of
20 healthy subjects using a 20 IU/kg single-dose. The initial study
evaluated
the original 150 IU/mL HYPERRAB S/D in 8 subjects and the second study
evaluated HYPERRAB in 12 subjects. The original study of HYPERRAB S/D
reported headache (1/8; 13%).
In the study with HYPERRAB at 300 IU/mL, 5 subjects (5/12; 42%)
experienced at least 1 adverse reaction. These were: injection site
pain (4/12;
33%), injection site nodule (1/12; 8%), abdominal pain (1/12; 8%),
diarrhea
(1/12; 8%), flatulence (1/12; 8%), headache (1/12; 8%), nasal
congestion
(1/12; 8%), and orophar