at 300 mg q2 wks based on AUC.
6. Pharmaceutical particulars
6.1 List of excipients
Disodium phosphate dihydrate
Citric acid monohydrate
Histidine
Sodium chloride
Polysorbate 80
Water for injections
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C and for 8 hours at 2°C to 8°C. From a microbiological point of view, unless the method of preparation precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. TAKHZYRO should be administered within 2 hours of preparing the dosing syringe. If not administered immediately after preparation, the syringe may be stored in the refrigerator (2°C to 8°C), protected from light and administered within 8 hours.
6.4 Special precautions for storage
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Keep vial in the outer carton in order to protect from light.
Vials may be stored below 25°C for a single period of 14 days, but not beyond the expiry date. Do not return TAKHZYRO to refrigerated storage after storage at room temperature.
6.5 Nature and contents of container
2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with violet flip-off cap. Pack size of 1 vial.
Each pack also contains the following items:
• Empty 3 ml syringe
• 18G vial access needle
• 27G x ½ inch (0.4 x 13 mm) injection needle
6.6 Special precautions for disposal and other handling
Lanadelumab is provided in single use vials.
Before use, each vial should be visually inspected for appearance. The solution should be clear or slightly yellow. Solutions that are discoloured or contain particles should not be used.
Avoid vigorous agitation.
Administration steps
Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial into the syringe using an 18 gauge needle.
Change the needle on the syringe to a 27 gauge needle or other needle suitable for SC injection. Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).
Discard the vial with any unused contents.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
All needles and syringes should be disposed of in a sharps container.
7. Marketing authorisation holder
Shire Pharmaceuticals Ireland Limited
Blocks 2 & 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland
Tel: +44(0)1256 894 959
E-mail: medinfoEMEA@shire.com
8. Marketing authorisation number(s)
EU/1/18/1340/001
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 22 November 2018
10. Date of revision of the text
November 2018
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. |
