Cap and seal

Control unit

Power button

Connection cord socket

Medication reservoir*

Aerosol head

Aerosol chamber*

Inspiratory valve

Mouthpiece

Preassembled nebuliser parts*

A quick reference guide. For full details, please read and take note of the Instructions For Use.

Assembly and inhalation

1

Assemble Hold the nebuliser horizontally to inhale

2

PARI GmbH – Spezialisten für effektive Inhalation, Moosstraße 3, D-82319 Starnberg, Tel: 0049 (0) 8151 / 279 - 220

With mouthpiece

With mask (for ages 2 and older)

A note about the medication reservoir: A small amount of medication that must not be used is left in the reservoir. It must be disposed of. Similarquantities of medication also remain unused in the PARI LC PLUS® nozzle nebuliser.

* The aerosol chamber and the medication reservoir are preassembled and cannot be taken apart.

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eFlow rapid Arzneimittelkarte für Ärzte EN 20.09.2006 14:05 Uhr Seite 1

Practitioner´s information: Inhalation therapy with eFlow®rapid:

Inhalation Solutions & Treatment Time

Active Agent

Concentration1)

SubstanceClass1)

eFlow® rapid

DetailsTOR

g/min 4)MMDμm 4)

RF %< 5μm 4)

Time

Min

Tobramycin

300 mg/5 ml

Aminoglycoside Antibiotic

Serum level is comparable to standard therapy usingthe PARI LC PLUS® nebuliser. Serum value approx. 1 μg/ml data on file (n=9).2)

Tested with TOBI® (Chiron/Novartis)0.50 3.9 73 6-8

Colistimethate sodium

79 mg (1 Mio units) /3 ml

Polymyxine Polypeptide Antibiotic

Colistin powder has to be dissolved carefully in 3 ml0.9 % sodium chloride solution. Tested with Colistin CF (Grünenthal)

0.58 3.9 69 3-4

Salbutamol

2.5 mg/2.5 ml

BronchodilatorBeta 2 mimetic

Comparable treatment safety: Heart rate pre and postdelivery of Salbutamol (10 min after inhalation) is comparable to LC PLUS® nebuliser. Data on file (n=10).2)

Tested with Sultanol® forte (Glaxo Smith Kline)

0.68 4.3 64 2-3

Ipratropiumbromide

500 μg/2 ml

BronchodilatorAnticholinergic

Tested with Atrovent® (Boehringer Ingelheim)0.69 4.3 63 1-2

Dornase alfa

2.5 mg/2.5 ml

Mucolytic agent Enzymatic activity remains largely stable after nebulization (90%) as for PARI LC PLUS®

nebuliser 2)3). Tested with Pulmozyme® (Roche)0.61 3.9 72 2-3

Acetylcysteine

300 mg/3 ml

Mucolytic Tested with Fluimucil® (Zambon)0.60 4.1 70 4-5

Medical product:Isotonic sodium chloride

solution (0.9 %) 2.5 ml

PARI NaCl Inhalation Solution

Secretolytic Individual treatment schedule.Tested with PARI NaCl Inhalation Solution

0.70 4.3 67 2-3

Dispensed hypertonic

saline solution

(Sodium chloride 5.8%) 2.5 ml

Secretolytic Individual treatment schedule.Tested with dispensed saline solution 5.8 % 0.69 4.2 69 2-3

1) These agents are approved for inhalation therapy in Germany. 2) Seemann et al: Improving aerosol drug delivery in CF therapy. European Cystic Fibrosis Society, 28 th European Cystic FibrosisConference, Crete, Greece, June 22-25, 2005. 3) Lichtinghagen (2004 and 2005), MHH. 4) PARI internal tests, measured with the Malvern MasterSizer X at 23°C and 50% relative humidity. Inspiratory flow 20 l/min. TOR, MMD, RF, time (mean values).

eFlow rapid Arzneimittelkarte für Ärzte EN 20.09.2006 14:05 Uhr Seite 2