Determine the volume of the solution required:

• based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:

• based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:

The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution. Do not use with glucose-containing solutions (see section 6.2). The bag should be gently inverted to mix the solution in order to avoid foaming. Once the infusion is prepared it should be administered immediately. If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.

No incompatibilities between Ontruzant and polyvinylchloride, polyethylene or polypropylene bags have been observed.

Ontruzant is for single-use only, as the product contains no preservatives. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

8. Marketing authorisation number(s)

EU/1/17/1241/001

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 15 November 2017

10. Date of revision of the text

8 November 2018

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.