IMMUKIN Solution for injection Ref.[9679] Active ingredients: Interferon gamma-1b

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Clinigen Healthcare Limited, Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom

Product name and form

IMMUKIN 2 × 106 IU (0.1 mg) solution for injection.

Pharmaceutical Form

Solution for injection.

A clear, colourless solution.

Qualitative and quantitative composition

Each vial (0,5 ml) contains 2 × 106 IU (0.1 mg) recombinant human interferon gamma-1b. Interferon gamma-1b is produced in an E. coli expression system.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Interferon gamma-1b

It is presumed that interferon gamma-1b increases macrophage cytotoxicity by enhancing the respiratory burst via generation of toxic oxygen metabolites capable of mediating the killing of intracellular micro-organisms.

List of Excipients

D-Mannitol
Disodium succinate hexahydrate
Polysorbate 20
Succinic acid
Water for injections

Pack sizes and marketing

3 ml glass vials (Type I borosilicate glass) which are stoppered with grey butyl rubber stoppers with aluminium/polypropylene flip-off type caps.

Pack sizes: 1, 3, 5, 6 and 12 vial(s) in one folding box. Not all pack sizes may be marketed.

Marketing authorization holder

Clinigen Healthcare Limited, Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom

Marketing authorization dates and numbers

PL 31644/0004

29/09/2007

Drugs

Drug Countries
IMMUKIN Hong Kong, Malta, United Kingdom

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