Rabies Immune Globulin Human human rabies immunoglobulin

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Rabies Immune Globulin Human human rabies immunoglobulin Powered By Docstoc
					                                    human rabies immunoglobulin
                                             solution for injections
                                immunoglobulinum humanum rabicum

  - total proteins (³ 90% immune globulin G)
                    ³                                                   100.0 - 180.0 g/l
    specific anti-rabies antibodies                              not less than 100 IU/ml
  - glycine (stabilizer)                                                         22.5 g/l
  - thiomersal (preservative)                                      not more than 0.1 g/l
pharmaceutical form and packaging
  Sterile solution for parenteral administration
  -2 ml vial (not less than 200 IU) in a box
  -5 ml vial (not less than 500 IU) in a box

pharmacotherapeutic group (ATC code)
  J 06 B B 05 (Human rabies immunoglobulin)

name and address of manufacturer and marketing authorisation holder
  Institute of Immunology, Inc., Rockefellerova 2, HR-10000 Zagreb, Republic of Croatia

legal category
  Subject to medical prescription, supply through medical institutions only.

pharmacological properties
  Human rabies immunoglobulin is a clear, colorless to pale-yellow, sterile solution of immunoglobulin
  fraction of plasma. It is obtained through a procedure of cold ethanol fractionation, from healthy
  donors' plasma, who were actively immunized against rabies. Donors were syphilis, HBs-antigen, and
  HIV type 1 and 2 and HCV antibodies negative. Absence of HCV-antigen is controlled by PCR
  At least 90% of total proteins in the solution are immunoglobulins, mostly immunoglobulin G (lgG).
  Specific activity of anti-rabies antibodies is not less than 100 IU/ml (determined by International
  Reference Preparation).
  Human rabies immunoglobulin specifically neutralizes rabies virus. The amount of antibodies in the
  organism is peaking 3-7 days after administration. Human rabies immunoglobulin has a half-life in
  circulation of about 17-25 days. The preparation complies with the World Health Organization (WHO)
  and the European Pharmacopoeia (Ph.Eur.) requirements.

therapeutic indications
  Human rabies immunoglobulin is indicated for persons not previously immunized against rabies and
  who suffered serious injuries: bites, deep facial, neck, hand and feet scars and multiple bites and
  wounds, or deep scars caused by wild and domestic animals which are rabid or suspected to be rabid.
  Human rabies immunoglobulin must always be used in combination with rabies vaccine.

  Because of life-threatening risk due to rabies, there are no contraindications to the administration of
  rabies immunoglobulin. In case of hypersensitivity to homologous (human) immunoglobulins, all
  measures to treat anaphylactic shock should be taken.

special warnings and special precautions for use
  - intravenous administration of human rabies immunoglobulin is strictly contraindicated (possibility of
    anaphylactic reaction)
  - individuals who are deficient in IgA have the potential for developing IgA antibodies and may have
    anaphilactic reactions after administration of blood components containing IgA.
  - hypersensitivity to any components of drug (thiomersal)
  - individuals hypersensitive to human blood preparations should be given systemic antihistamines 1
    hour before immunoglobulin administration.
  Antishock therapy should be applied in case of possible anaphilactic reaction!
  When medicines are made from human blood or plasma, certain measures are put in place to prevent
  infections being passed on to patients. These include careful selection of blood and plasma donors to
  make sure those at risk of carrying infections are excluded, and the testing of each donation and pools
  of plasma for signs of virus/infections. Manufacturing of these products also include steps in the
  processing of the blood or plasma that can inactivate or remove viruses.
  Despite these measures, when medicines prepared from human blood or plasma are administered,
  the possibility of passing on infection cannot be totaly excluded. This also applies to any unknown or
  emerging viruses or other types of infections. The measures taken are considered effective for
  enveloped viruses.
Institute of Immunology Inc., Rockefellerova 2, HR-10000 Zagreb
         Phone: +385 1 46 84 500; Fax: +385 1 46 84 303