Hepatitis B immunoglobulin human 200units/2ml solution for injection vials

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Hepatitis B immunoglobulin human

Tersedia dari:

Bio Products Laboratory Ltd

Kode ATC:

J06BB04

INN (Nama Internasional):

Hepatitis B immunoglobulin human

Dosis:

100unit/1ml

Bentuk farmasi:

Solution for injection

Rute administrasi :

Intramuscular

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 14050200; GTIN: 5019943000324

Selebaran informasi

PATIENT INFORMATION LEAFLET
HUMAN HEPATITIS B
IMMUNOGLOBULIN
100 IU/ML STERILE SOLUTION
SHDNL4
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 Hepatitis B Immunoglobulin is and what it is used for
2. Before you are given Human Hepatitis B Immunoglobulin
3. How you are given Human Hepatitis B Immunoglobulin
4. Possible side effects
5. How to store Human Hepatitis B Immunoglobulin
6.
Further information
1. WHAT HUMAN HEPATITIS B IMMUNOGLOBULIN
IS AND WHAT IT IS USED FOR
This product is a solution containing a large quantity of hepatitis B
antibodies.
It is prepared from blood plasma from screened donors and
virally-inactivated
during manufacture. It is used to protect against infection by the
hepatitis B
virus and is normally given with hepatitis B vaccine. Your doctor will
explain
further why this medicine has been given to you.
This product is usually given to you if:
•
you have not had previous vaccination, or have not been properly
vaccinated, to hepatitis B and have been accidentally exposed to
infection
by skin pricks, cuts, spillage into the eye or mouth, from infectious
material
such as blood, or from bites.
•
you are having kidney dialysis while waiting for vaccination to be
fully
effective.
•
you have not responded to hepatitis B vaccination, but you remain at
risk of
infection, perhaps because of your job.
•
you are within seven days of sexual contact with someone who has
hepatitis B.
The product can also be given to newborn babies whose mother has
hepatitis B.
Human Hepatitis B Imm

Karakteristik produk

OBJECT 1
HUMAN HEPATITIS B IMMUNOGLOBULIN
Summary of Product Characteristics Updated 05-Oct-2016 | Bio Products
Laboratory Limited
1. Name of the medicinal product
Human Hepatitis B Immunoglobulin, 100 IU/mL sterile solution
2. Qualitative and quantitative composition
Human Hepatitis B Immunoglobulin contains human protein, 10-100 g/L,
of which at least 95% is IgG.
The concentration of specific IgG to hepatitis B virus is 100 IU/mL in
nominal 200 IU and 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
Immunoprophylaxis of hepatitis B
- In case of accidental exposure _e.g._ skin pricks, contamination of
abrasions, spillage into eye or mouth,
bites or scratches, in non-immunised subjects (including persons whose
vaccination is incomplete or
status unknown).
- In haemodialysed patients, until vaccination has become effective.
- In the newborn of a hepatitis B virus carrier-mother (if birthweight
≤1,500g irrespective of e-antigen
status of mother; if >1,500g irrespective of mother's HBeAg status but
not necessary if she is known to be
anti-HBe positive).
- In subjects who did not show an immune response (<10 IU/L of
hepatitis B antibodies) after vaccination
and for whom a continuous prevention is necessary due to the
continuous risk of being infected with
hepatitis B.
- Sexual contacts of patients with acute hepatitis B within one week
of last contact.
- Sexual contacts of newly diagnosed chronic hepatitis B if
unprotected contact within the last week.
4.2 Posology and method of administration
POSOLOGY
- Prevention of hepatitis B in case of accidental exposure in
non-immunised subjects or in subjects who
have had no more than a single dose of vaccine:
At least 500 IU, depending on the intensity of exposure, as soon as
possible after exposure, and preferab