Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Sodium chloride
Calcium chloride dihydrate
Water for injection
6.2    Incompatibilities

Pulmozyme is an unbuffered aqueous solution and should not be diluted or mixed with other drugs or solutions in the nebuliser bowl. Mixing of this solution could lead to adverse structural and/or functional changes in Pulmozyme or the admixed compound.

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 (2°C - 8°C).
Keep the ampoule in the outer carton in order to protect from light.

A single brief exposure to elevated temperatures (less than or equal to 24 hours at up to 30°C) does not affect product stability.

6.5    Nature and contents of container

2.5 ml of solution for inhalation in an ampoule (low density polyethylene plastic).
Pack sizes of 30.
6.6    Special precautions for disposal and other handling

The contents of one 2.5 mg (2500 U) single-use ampoule of Pulmozyme sterile solution for inhalation should be inhaled once a day using a recommended nebuliser.

•     Pulmozyme should not be mixed with other drugs or solutions in the nebuliser (see section 6.2).
•     Pulmozyme may be used in conjugation with a jet nebuliser/compressor system, such as the Hudson T Up-draft II/Pulmo-Aide, Airlife Misty/Pulmo-Aide, customised Respirgard/Pulmo-Aide, or AcornII/Pulmo-Aide. Not all types may be available.
•     Pulmozyme may also be used in conjunction with a reusable nebuliser system, such as the Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Aiolos/2 Aiolos, Side Stream/CR50 or MobilAire or Porta-Neb. Not all types may be available.
•     The Pari eRapid nebuliser, a general purpose electronic vibrating membrane nebuliser may be used. Parity between the eFlow Rapid electronic nebuliser and the LC Plus jet nebuliser has been demonstrated in vitro and in vivo. The average droplet size distribution of the aerosol generated by the eFlow Rapid nebuliser compared with the LC Plus jet nebuliser is shown below, using an adult breath simulator profile. The mass median aerodynamic diameter (MMAD) was 4.8 ± 0.4 µm (n=16) for e Flow Rapid and 4.6 ± 0.4 µm (n=12) for LC Plus. The geometric standard deviation (GSD) was 1.80 ± 0.11 for eFlow Rapid and 2.14 ± 0.04 for LC Plus. The drug delivery rate was 380 ± 60 µg/min (n=88) for eFlow Rapid and 93 ± 16 µg/min (n=40) for LC Plus. The total drug delivered was 567 ± 62 µg for eFlow Rapid and 570 ± 80 µg for LC Plus. The Pari eFlow Rapid nebuliser should be used with the Pari EasyCare cleaning accessory and cleaning should be performed every seventh nebulisation cycle (a cycle being defined as a nebulisation of a single ampoule of Pulmozyme followed by cleaning and disinfecting in accordance with the PARI eFlow Rapid nebuliser system instruction for use).
Using the eFlow Rapid nebuliser without EasyCare cleaning accessory may lead to lower and more variable dose delivery.
•     Ultrasonic nebulisers may be unsuitable for delivery of Pulmozyme because they may inactivate Pulmozyme or have unacceptable aerosol delivery characteristics.
•    The manufacturers' instructions on the use and maintenance of the nebuliser and compressor should be followed.
•    Containment of the aerosol is not necessary.
•    Pulmozyme ampoules are for single administration only. Any unused product or waste material should be disposed of in accordance with local requirements.

7.     MARKETING AUTHORISATION HOLDER
Roche Pharmaceuticals (Israel) Ltd., P.O. Box 6391, Hod Hasharon 4524079.

8.     MARKETING AUTHORISATION NUMBER(S)
101-96-28175-00