Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Dipalmitoylphosphatidylcholine (DPPC)
Cholesterol High Purity (HP)
Sodium chloride
Sodium hydroxide
Water for injection

6.2    Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4    Special precautions for storage

Store in a refrigerator (2oC – 8oC).

Do not freeze.
ARIKAYCE liposomal 590 mg can be stored at room temperature below 25 °C for up to 4 weeks.

6.5     Nature and contents of container

Each 10 mL clear, Type I borosilicate glass vial is sealed with a bromobutyl rubber stopper and aluminium seal with a flip-tear off cap.

Pack-size of 28 vials. The carton also contains the Lamira Nebuliser Handset and 4 aerosol heads.

6.6     Special precautions for disposal and other handling
Discard any vial that has been frozen.
Once at room temperature, any unused medicine must be discarded at the end of 4 weeks.

If the current dose is refrigerated, the vial of ARIKAYCE liposomal 590mg should be removed from the refrigerator and be allowed to come to room temperature. Prepare ARIKAYCE liposomal 590mg by shakingthe vial vigorously until the contents appear uniform and well mixed. Open the vial of ARIKAYCE liposomal 590mg by flipping up the plastic top of the vial, then pulling downward to loosen the metal ring. Carefully remove the metal ring and remove the rubber stopper. Pour the content of the ARIKAYCE liposomal 590 mg vial into the medicine reservoir of the Lamira Nebuliser Handset.

ARIKAYCE liposomal 590 mg is administered by oral inhalation via nebulization using the Lamira Nebuliser System. ARIKAYCE liposomal 590 mg should only be used with the Lamira Nebuliser System (nebuliser handset, aerosol head, and controller). ARIKAYCE liposomal 590 mg should not be used with any other type of inhalation delivery system. Do not put other medicinal products in the Lamira Nebuliser Handset.

Any unused product or waste material should be disposed of in accordance with local requirements.

7.      MANUFACTUTER

Insmed Netherlands B.V.
Stadsplateau 7
3521 AZ Utrecht,
Netherlands

8.      REGISTRATION HOLDER
TrueMed Ltd.,
10 Beni Gaon St., Poleg Industrial Park,
P.O.B 8105, Netanya 4250499