Intron-A

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Interferon alfa-2b 5 MIU/mL;  

Available from:

Schering-Plough a division of Schering-Plough Animal Health Limited

INN (International Name):

Interferon alfa-2b 5 MIU/mL

Dosage:

5 MIU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Interferon alfa-2b 5 MIU/mL   Excipient: Albumin Dibasic sodium phosphate Glycine Methyl hydroxybenzoate Monobasic sodium phosphate monohydrate Propyl hydroxybenzoate Water for injection

Units in package:

Vial, glass, multi-dose, 2mL vial, 10 MIU

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Schering-Plough Inc

Product summary:

Package - Contents - Shelf Life: Vial, glass, multi-dose, 2mL vial - 10 MIU - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, multi-dose, 5mL vial - 25 MIU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1995-03-13

Summary of Product characteristics

Ref: LRN# 030500-INT-SOi-PIPB-2 A110120 Version 5.0
_  _
 Page 1 
NEW ZEALAND DATA SHEET 
INTRON
®
 A 
NAME OF DRUG 
Interferon alfa-2b (rbe) 

DESCRIPTION 
INTRON A is a sterile, stable formulation of highly purified
interferon alfa-2b produced by 
recombinant DNA techniques. Recombinant interferon alfa-2b is
a water soluble protein with a 
molecular weight of approximately 19,300 daltons. It is
obtained from a clone of _E. coli_ which 
has a genetically engineered plasmid containing an interferon
alfa-2 gene from human 
leucocytes. 
The activity of INTRON A is expressed in terms of International
Units (IU). The specific activity 
of INTRON A is approximately 2.6 x 10
8
 IU/mg protein. 
PRESENTATION 
INTRON A INJECTABLE (HSA-FREE) SOLUTION 
INTRON A HSA-free Injectable Solution is a clear, colourless
solution and is presented in a 
single dose vial. Each vial of INTRON A HSA-free Injectable Solution
contains either 10 million 
IU/1 mL, 18 million IU/3 mL or 25 million IU/2.5 mL
of recombinant interferon alfa-2b. The vials 
also contain sodium phosphate dibasic, sodium phosphate monobasic,
disodium edetate, 
sodium chloride, polysorbate 80, water for injections and m-cresol as
preservative.  
PHARMACOLOGY

Interferons are a family of naturally occurring, small
protein molecules produced and secreted 
by cells in response to viral infections or various synthetic and
biological inducers. 
Interferons exert their cellular activities by binding to specific
membrane receptors on the cell 
surface. Preliminary studies to characterise these membrane
receptors and to determine the 
subsequent fate of the human interferon-receptor complex have
been carried out using 
125
I-
labelled recombinant interferon alfa-2b.
Human interferon receptors, as isolated from human 
lymphoblastoid (Daudi) cells, appear to
be highly asymmetric membrane proteins. They exhibit 
selectivity for human but not