CSL New Zealand Normal Immunoglobulin-VF Human Immunoglobulin G 320mg in 2mL, solution for injection, vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
23-11-2017

Toimeaine:

normal immunoglobulin, Quantity: 160 mg/mL

Saadav alates:

CSL Behring Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

normal immunoglobulin

Ravimvorm:

Injection, solution

Koostis:

Excipient Ingredients: glycine

Manustamisviis:

Intramuscular

Ühikuid pakis:

2 mL

Retsepti tüüp:

(S1) This Schedule is intentionally blank

Näidustused:

Normal Immunoglobulin-VF is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. It may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. In susceptible contacts of hepatitis A, measles and poliomyelitis, Normal Immunoglobulin-VF may be of value in preventing or modifying the disease. In general, the earlier in the incubation period of these diseases Normal Immunoglobulin-VF is given, the greater its effectiveness. Hepatitis A Routine passive protection is recommended in persons exposed less than one week previously for the following categories of individuals: - Household contacts of an index case, who have not already had hepatitis A or have no serological evidence of immunity to the virus. - Common source exposures. When a vehicle such as food or water is identified as a common source of infection for multiple hepatitis cases, administration of Normal Immunoglobulin-VF should be considered for all those exposed to the source. - Insstitutional contacts. - Staff in institutions where hepatitis is endemic. Routine prophylaxis is not recommended for school, office, factory or hospital contacts.

Toote kokkuvõte:

Visual Identification: Colourless, clear to opalescent; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2006-03-01