f the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
5.3 Preclinical safety data
There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies. Trastuzumab is not genotoxic. A study of trehalose, a major formulation excipient did not reveal any toxicities.
No long-term animal studies have been performed to establish the carcinogenic potential of trastuzumab, or to determine its effects on fertility in males.
6. Pharmaceutical particulars
6.1 List of excipients
Histidine
Histidine monohydrochloride
Trehalose dihydrate
Polysorbate 20
6.2 Incompatibilities
This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6.
KANJINTI should not be diluted with glucose solutions since these cause aggregation of the protein.
6.3 Shelf life
3 years.
After reconstitution with sterile water for injections, the reconstituted solution is physically and chemically stable for 48 hours at 2°C - 8°C. Any remaining reconstituted solution should be discarded.
Solutions of KANJINTI for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
From a microbiological point of view, the reconstituted solution and KANJINTI infusion solution should be used immediately. The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions of the reconstituted medicinal product, see section 6.3 and 6.6.
6.5 Nature and contents of container
KANJINTI 150 mg powder for concentrate for solution for infusion
20 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 150 mg of trastuzumab.
arton contains one vial.
KANJINTI 420 mg powder for concentrate for solution for infusion
50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 420 mg of trastuzumab.
Each carton contains one vial.
6.6 Special precautions for disposal and other handling
KANJINTI should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of KANJINTI that can be withdrawn from the vial.
The reconstituted solution should not be frozen.
KANJINTI 150 mg powder for concentrate for solution for infusion
Appropriate aseptic technique should be used. Each 150 mg vial of KANJINTI is reconstituted with 7.2 mL of sterile water for injections (not supplied). Use of other reconstitution solvents should be avoided.
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.1. A |
