volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
KANJINTI 420 mg powder for concentrate for solution for infusion
Appropriate aseptic technique should be used. Each 420mg vial of KANJINTI is reconstituted with 20 mL of sterile water for injections (not supplied). Use of other reconstitution solvents should be avoided.
This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.1. A volume overage of 5% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
KANJINTI vial
Volume of sterile water for injections
Final concentration
150 mg vial
+
7.2 mL
=
21 mg/mL
420 mg vial
+
20 mL
=
21 mg/mL
Instructions for reconstitution
1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised KANJINTI, directing the stream into the lyophilised cake.
2) Swirl the vial gently to aid reconstitution. DO NOT SHAKE.
Slight foaming of the product upon reconstitution is not unusual. Allow the vial to stand undisturbed for approximately 5 minutes. The reconstituted KANJINTI results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
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The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/ml (0.9%) solution for injection. 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 discolouration prior to administration.
No incompatibilities between KANJINTI and polyvinylchloride, polyethylene or polypropylene bags have been observed.
KANJINTI 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
Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands
8. Marketing authorisation number(s)
EU/1/18/1281/001
EU/1/18/1281/002
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 16 May 2018
10. Date of revision of the text
September 2018
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. |
