Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Water for injections
L- Histidine
Sodium phosphate dibasic, dihydrate
Sodium chloride
Citric acid monohydrate
Polysorbate 80

6.2     Incompatibilities

Not applicable.
6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.

Vial only:
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 the solution (pre-filled syringe or vial) in the outer carton in order to protect from light.

The solution (pre-filled syringe or vial) 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.

When one pre-filled syringe from a multi-pack is removed from refrigeration, return the remaining pre-filled syringes to the refrigerator until future use when needed.

For storage conditions after first opening of the product in vial, see section 6.3.

6.5  Nature and contents of container
TAKHZYRO 150 mg solution for injection in pre-filled syringe
1 ml of solution in pre-filed syringe with a bromobutyl stopper, 27G x 13 mm staked needle and rigid needle cap. TAKHZYRO is available as unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.

TAKHZYRO 300 mg solution for injection in pre-filled syringe

2 ml of solution in pre-filled syringe with a bromobutyl stopper, 27G x 13 mm staked needle and rigid needle cap. TAKHZYRO is available as unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
TAKHZYRO 300 mg solution for injection in vial

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. TAKHZYRO is available as a single pack containing one 2 ml 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 
Not all pack sizes may be marketed.

6.6      Special precautions for disposal and other handling
Lanadelumab is provided in single use pre-filled syringes and vials.

Before use, TAKHZYRO solution 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
TAKHZYRO 150 mg solution for injection in pre-filled syringe
After removing the single use pre-filled syringe from the refrigerator, wait 15 minutes before injecting to allow the solution to reach room temperature. Caregiver should inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).

TAKHZYRO 300 mg solution for injection in pre-filled syringe
After removing the single use pre-filled syringe from the refrigerator, wait 15 minutes before injecting to allow the solution to reach room temperature. Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).

Each pre-filled syringe is for single use only. Discard the pre-filled syringe after injection is completed.

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.

TAKHZYRO 300 mg solution for injection in vial
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 subcutaneous injection. Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).

Discard the vial with any unused contents.