IMUKIN interferon gamma-1b recombinant human 2 million IU (100 micrograms)/0.5mL injection vial, Link Medical Products Pty Ltd , CON-1463

The name of the medicine supplied in the UK (IMMUKIN) is spelt differently to the Australian (AU) name (IMUKIN). The quantity or proportion of all active ingredients in the medicine. The strength on the UK labelling (2x10^6 IU (0.1 mg)) is presented differently on the AU labelling (2 million IU (100 microgram)). The name of the medicine and the name(s) of active ingredient(s) on the main label must appear as a cohesive unit by the placing of the name and quantity of each active ingredient together on separate lines of text. The name of the active ingredient and quantity of active ingredient are not in a cohesive unit. The name and quantity of each excipient in the medicine, expressed for single dose injections (including concentrated solutions for injection) - as the nominal mass of that excipient (not including any overage) in the stated volume of fill of the injection in the container. No details of excipient masses are presented and Australian approved names are not used for all excipients. Where the medicine is supplied in a container with potential for multidose use, such as a vial or pre-filled syringe, and an antimicrobial preservative is not included in the medicine - the statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect. No wording for this requirement is presented. The name of the sponsor or distributor as it appears on the primary pack, or registered trademark if it readily identifies the sponsor or distributor of the medicine. The name of the sponsor is not included on the vial label. A statement of quantity for 1 microgram up to 999 micrograms inclusive must be expressed in terms of micrograms. The strength of the active on the UK labelling is presented as 0.1 mg and not 100 micrograms. For a liquid biological medicine or a biological medicine required to be prepared before use, the potency: must be included on the label of the medicine; and must be expressed as potency units, or weight of active ingredient per dose or per unit volume, or as the volume which contains the recommended dose. Potency is not expressed in this manner. ‘Store at 2°C to 8°C (Refrigerate. Do not freeze)’. The storage information is not displayed as one of the "permitted statement of storage temperature conditions”.