Tobi Solution
Product Images NDC 49502-345

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Tobi (NDC 49502-345). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Viatris Specialty Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Tobramycin Structural Formula (Image 01)

Chemical structure of Tobramycin, illustrating its molecular arrangement of amino sugars and hydroxyl groups. The diagram shows ring structures with attached amine and hydroxyl functional groups, characteristic of this antibiotic.*

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Figure 1: Relative Change From Baseline In Fev1% Predicted (Image 02)

Line graph depicting average relative change in predicted FEV1 (%) over 24 weeks, comparing TOBI inhalation solution to placebo in two clinical studies. The graph shows data points for Study 1 (n=109 for TOBI, n=114 for placebo) and Study 2 (n=149 for TOBI, n=148 for placebo) with time intervals marked in weeks and periods of drug administration indicated on the x-axis.*

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Figure 2: Absolute Change From Baseline In Log10 Cfus (Image 03)

A line graph depicting the average change of log10 CFUs over a 24-week period, comparing TOBI treatment and placebo in two studies. The x-axis represents weeks, the y-axis shows average change in log10 CFUs, with time points marked where the drug was administered. Four distinct lines represent Study 1 and Study 2 for both placebo and TOBI groups.*

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Instructions For Use Figure A (Image 04)

An instructional diagram illustrating the components of a respiratory nebulizer setup for inhalation medication delivery. It labels parts including an air compressor, nebulizer cup, inspiratory valve cap, ampule, mouthpiece, clean paper or cloth towels, and tubing, demonstrating how these parts assemble or relate to each other.*

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Instructions For Use Figure B (Image 05)

An instructional illustration showing hands demonstrating how to invert two TOBI (Tobramycin) 300 mg/5mL solution ampules, likely as part of the preparation process for oral or inhalation administration.*

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Instructions For Use Figure C (Image 06)

Packaging label of a single-use ampule for TOBI (Tobramycin) 300 mg/5 mL solution for oral respiratory (inhalation) use. The image shows the ampule with a marked expiration date area and distribution information indicating distribution by Mylan Specialty L.P., Morgantown, WV 26505.*

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Instructions For Use Figure D (Image 07)

An instructional diagram depicting the assembly of a nebulizer device for inhalation therapy. The image shows labeled components including the nebulizer top, nebulizer cup, inspiratory valve cap, mouthpiece, and tubing, with hands demonstrating how the nebulizer top is placed onto the nebulizer cup.*

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Instructions For Use Figure E (Image 08)

An instructional diagram illustrating the assembly of a nebulizer for inhalation. It shows a hand rotating and placing the nebulizer insert into the nebulizer cup, with labels indicating the top, nebulizer insert, and nebulizer cup parts.*

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Instructions For Use Figure F (Image 09)

An instructional illustration showing a nebulizer cup labeled with its top part, placed alongside clean paper or cloth towels. The drawing depicts components likely used for respiratory inhalation of the medication Tobramycin solution.*

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Instructions For Use Figure G (Image 10)

Illustration showing a hand placing or retrieving a component labeled "Pulmo-Aide" from a rectangular device, likely a medical nebulizer or respiratory equipment accessory related to inhalation therapy.*

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Instructions For Use Figure H (Image 11)

An instructional illustration showing a hand unplugging a two-prong electrical plug from a wall outlet, indicated by a directional arrow pointing away from the outlet.*

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Instructions For Use Figure I (Image 12)

An instructional illustration showing a hand holding a TOBI (Tobramycin) 300 mg/5 mL solution ampule. The diagram highlights the bottom tab on the ampule, indicating where to snap or open it for use.*

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Instructions For Use Figure J (Image 13)

An instructional illustration showing a hand holding a dropper bottle above an inhalation device. A liquid drop is depicted falling from the dropper into the device's top opening, indicating how to add the solution for respiratory inhalation use.*

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Instructions For Use Figure K (Image 14)

Illustration showing the assembly of a nebulizer for TOBI (Tobramycin) inhalation solution. It depicts the nebulizer cup, stem, nebulizer top with a semi-circle marker, and the nebulizer outlet, indicating how to fit the top onto the cup properly.*

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Instructions For Use Figure L (Image 15)

An instructional illustration showing the assembly of a mouthpiece onto a nebulizer cup. The diagram labels the parts as Mouthpiece, Nebulizer Outlet, and Nebulizer Cup, indicating the mouthpiece connecting to the outlet on the cup.*

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Instructions For Use Figure M (Image 16)

An instructional illustration showing the assembly of the inspiratory valve cap onto the mouthpiece of a respiratory solution delivery device. The diagram includes arrows indicating the placement of the valve cap on top of the device.*

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Instructions For Use Figure N (Image 17)

An instructional diagram showing the parts of an inhalation device for TOBI (Tobramycin) solution. It depicts the main inhaler unit with a handle and air intake label, alongside a detachable mouthpiece connected via arrows indicating assembly direction.*

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Instructions For Use Figure O (Image 18)

An instructional illustration showing a hand interacting with the side of a Pulmo-Aide device, which is a type of nebulizer compressor used for respiratory inhalation therapy. The image focuses on adjusting or pressing a button or switch on the device.*

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Instructions For Use Figure P (Image 19)

An instructional illustration showing a handheld nebulizer device in use, emitting aerosol mist from the mouthpiece. The device is designed for respiratory inhalation of medication, with a mouthpiece, a medication cup on top, and an air tubing connection extending downward.*

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Instructions For Use Figure Q (Image 20)

An instructional illustration showing a person using a respiratory inhalation device with a nose clip secured on the nose. The diagram highlights the placement of the nose clip during the administration of the inhaled medication.*

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Tobramycin Inhalation Solution Carton Label (Image 21)

TOBI Tobramycin Inhalation Solution, USP 300 mg/5 mL packaging label. The box is blue with a white gradient and features the Mylan logo. It contains 56 single-use 5 mL ampules intended for respiratory inhalation, with storage instructions to keep refrigerated and protect from intense light. Manufacturer and lot/expiration details are also visible on the label.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.