Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
Ontruzant 150 mg powder for concentrate for solution for infusion.
Ontruzant 420 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White to pale yellow lyophilised powder. |
Ontruzant 150 mg powder for concentrate for solution for infusion: One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by several chromatography steps including specific viral inactivation and removal procedures.
Ontruzant 420 mg powder for concentrate for solution for infusion: One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by several chromatography steps including specific viral inactivation and removal procedures.
The reconstituted Ontruzant solution contains 21 mg/mL of trastuzumab.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Trastuzumab |
Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). ฮคrastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. |
| List of Excipients |
|---|
|
L-histidine hydrochloride monohydrate |
Ontruzant 150 mg powder for concentrate for solution for infusion: One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
Each carton contains one vial.
Ontruzant 420 mg powder for concentrate for solution for infusion: One 40 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab.
Each carton contains one vial.
Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
EU/1/17/1241/001
EU/1/17/1241/002
Date of first authorisation: 15 November 2017
Date of latest renewal: 19 July 2022
| Drug | Countries | |
|---|---|---|
| ONTRUZANT | Austria, Australia, Brazil, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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