Rx Item-Kitabis Pak 300Mg/5Ml Amp 5Ml By Pari Respiratory Equipment

KITABIS PAK- tobramycin solution
Pari Respiratory Equipment

1. INDICATIONS AND USAGE

KITABIS PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].

2. DOSAGE AND ADMINISTRATION

2.1 Dosing Information
KITABIS PAK is a co-packaging of tobramycin inhalation solution ampules with a PARI LC PLUS Reusable Nebulizer. Administer as follows: One single-use ampule (300 mg /5 mL) of tobramycin inhalation solution twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug.
The 300 mg/5mL dose of tobramycin inhalation solution is the same for all patients regardless of age or weight.
The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
2.2 Administration of Tobramycin Inhalation Solution


Each dose of tobramycin inhalation solution is administered by oral inhalation using only the co-packaged PARI LC PLUS Reusable Nebulizer (Model No. 022B81-T) included in the KITABIS PAK, along with a DeVilbiss Pulmo-Aide air compressor (Model No. 5650D).

Tobramycin inhalation solution is not for subcutaneous, intravenous or intrathecal administration.

Prior to administration, read the Patient Information /Instructions for Use for KITABIS PAK for detailed information on how to use KITABIS PAK and follow the manufacturer�s instructions for use and care of the DeVilbiss Pulmo-Aide air compressor.

The entire tobramycin inhalation solution treatment should take approximately 15 minutes to complete. Continue treatment until all the tobramycin inhalation solution has been delivered, and there is no longer any mist being produced.

Tobramycin inhalation solution should not be diluted or mixed with other drugs including dornase alfa (Pulmozyme�) in the nebulizer. Instruct patients on multiple therapies to take their medications prior to inhaling the tobramycin inhalation solution, or as directed by their physician.

Tobramycin inhalation solution should not be used if it is cloudy, if there are particles in the solution, or if it has been stored at room temperature for more than 28 days.

3. DOSAGE FORMS AND STRENGTH

Inhalation solution: 300 mg/5mL in a single-use ampule

RX ITEM-Kitabis Pak 300Mg/5Ml Amp 5Ml By
NDC 24492-0850-56 UPC/GTIN No.3-24492-85056-2 Mfg.Part No.85056

Kitabis Pak 300Mg/5Ml Amp 5Ml By Pari Re
BRAND: KITABIS-PAK NDC: 24492-0850-56,24492085056 UPC: 3-24492-85056-2,324492850562 Pari Respiratory Equip Inc

TOBRAMYCIN/NEBULIZER INHA
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