HiPhi — SUMMARY OF PRODUCT CHARACTERISTICS

Multipacks containing 12 (3 packs of 4) 25 mg or 50 mg pre-filled syringes or 8 (2 packs of 4) or 24 (6 packs of 4) 25 mg pre-filled syringes of Erelzi. Not all pack sizes may be marketed. Erelzi 50 mg solution for injection in pre-filled pen Erelzi is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label. The syringe inside the pen is made from clear type I glass with a stainless steel 29 gauge 12.7 mm needle and an inner rubber needle cap (thermoplastic elastomer) and a rubber plunger stopper (bromobutyl rubber), containing 1.0 ml of solution. Cartons of 1, 2 or 4 pre-filled pens.

Multipacks containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling Instructions for use and handling of the Erelzi pre-filled syringe Before injection, Erelzi single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cap should not be removed while allowing the pre-filled syringe to reach room temperature. The solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.

Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe". Instructions for use and handling of the Erelzi pre-filled pen Before injection, Erelzi single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cap should not be removed while allowing the pre-filled pen to reach room temperature. By looking through the viewing window, the solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.

Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled pen". Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria 8. MARKETING AUTHORISATION NUMBER(S) Erelzi 25 mg solution for injection in pre-filled syringe EU/1/17/1195/001 31