Rabies immunoglobulin human 500unit solution for injection vials

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Rabies immunoglobulin human

Dostupno od:

Bio Products Laboratory Ltd

ATC koda:

J06BB05

INN (International ime):

Rabies immunoglobulin human

Doziranje:

500unit

Farmaceutski oblik:

Solution for injection

Administracija rute:

Intramuscular; Subcutaneous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 14050200; GTIN: 5019943000355

Uputa o lijeku

PATIENT INFORMATION LEAFLET
HUMAN RABIES
IMMUNOGLOBULIN
NOT LESS THAN 150 IU/ML SOLUTION FOR INJECTION
SRCNL4
PLEASE READ ALL OF THIS LEAFL ET CAREFULLY BEFORE USING THIS MEDICINE.
•
Keep this leafl et. You may need to read it again.
•
If you have any further questions, please ask your doctor.
•
This medicine has been prescribed for you personally. Do not pass it
on to
others. It may harm them, even if their symptoms are the same as
yours.
•
If any of the side effects get serious, or if you notice any side
effects not
listed in this leafl et, please tell your doctor.
Is this leafl et hard to see or read? Phone [phone].
IN THIS LEAFL ET:
1. What Human Rabies Immunoglobulin is and what it is used for
2. Before you are given Human Rabies Immunoglobulin
3. How you are given Human Rabies Immunoglobulin
4. Possible side effects
5. How to store Human Rabies Immunoglobulin
6.
Further information
1. WHAT HUMAN RABIES IMMUNOGLOBULIN IS
AND WHAT IT IS USED FOR
This product is a solution containing a large quantity of rabies
antibodies. It
is prepared from blood plasma from screened donors and
virally-inactivated
during manufacture.
It is used to protect you against rabies and is given with fi rst
dose of rabies
vaccine, or not more than 7 days later. Your doctor will explain
further why this
medicine has been given to you.
This product is usually given to you if:
•
you have been bitten, scratched or received any other injury from a
suspected rabid animal or you may have swallowed or breathed in tissue
such as saliva from a suspected rabid animal.
Human Rabies Immunoglobulin is given by injection around the wound and
into the muscle at the side of the thigh (intramuscular). Your doctor
or nurse
will give you the injection.
2. BEFORE YOU ARE GIVEN
HUMAN RABIES IMMUNOGLOBULIN
SPECIAL CARE MUST BE TAKEN WITH HUMAN RABIES IMMUNOGLOBULIN IF YOU:
•
DEVELOP AN ALLERGIC REACTION _(see Section 4 ‘Possible Side
Effects’ for a list of _
_these)._ IF YOU SUFFER FROM ANY OF THESE, OR JUST FEEL UNWELL, TELL

Svojstava lijeka

OBJECT 1
HUMAN RABIES IMMUNOGLOBULIN
Summary of Product Characteristics Updated 05-Oct-2016 | Bio Products
Laboratory Limited
1. Name of the medicinal product
Human Rabies Immunoglobulin, not less than 150 IU/mL solution for
injection
2. Qualitative and quantitative composition
Human Rabies Immunoglobulin contains human protein, 40-180 g/L of
which at least 95% is IgG. The
concentration of specific IgG to Rabies virus is not less than 150
IU/mL in nominal 500 IU vials. The
correct volume to give the stated potency is overprinted on the label.
This product is prepared from plasma from screened donors. Donors are
selected from the USA.
For excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Post-exposure prophylaxis of rabies infection in persons after
exposure to scratches, bites or other injuries
including mucous membrane contamination with infectious tissue, such
as saliva, caused by a suspected
rabid animal.
Human Rabies Immunoglobulin must always be used in combination with a
rabies vaccine.
4.2 Posology and method of administration
POSOLOGY
Post-exposure prophylaxis consists of a regimen of one dose of
immunoglobulin and full courses of rabies
vaccination. Rabies immunoglobulin and the first dose of rabies
vaccine should be given as soon as
possible after exposure. Additional doses of rabies vaccine should be
given according to official
guidelines or the manufacturer's instructions.
Rabies prophylaxis exclusively with simultaneous vaccination:
recommended dose of rabies
immunoglobulin is 20 IU/kg body weight.
If vaccine is given but treatment with human rabies immunoglobulin is
delayed, human rabies
immunoglobulin should still be given up to seven days after starting
the course of vaccine.
Because of the risk of interference with antibody production related
to vaccination, neither the dose
should be increased nor repeat rabies immunoglobulin be given (even if
the onset of the simultaneous
prophylaxis is delayed).
The volume of solutio