Arikayce Suspension
Product Images NDC 71558-590

Product Visual Gallery

This gallery contains 170 technical images submitted to the FDA as part of the official labeling for Arikayce (NDC 71558-590). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

FDA Label Image

Chemical Structure (Arikayce 01)

Chemical structure of Amikacin, the active ingredient in ARIKAYCE 590 mg/8.4 mL inhalation suspension. The diagram shows the molecular arrangement of Amikacin including its sugar rings and side chains, along with an associated sulfuric acid component (2 H2SO4).*

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Image (Arikayce 02)

A bar chart comparing the cumulative proportion of subjects achieving culture conversion over four months. It contrasts ARIKAYCE Plus Multi-Drug Regimen (N=224) and Multi-Drug Regimen Alone (N=112) across baseline, month 1, month 2, month 3, and month 4. The y-axis represents the percentage of subjects achieving culture conversion, with ARIKAYCE showing higher percentages at each month compared to the multi-drug regimen alone.*

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Figure (Arikayce 03)

An instructional illustration showing components of a respiratory inhalation device set for ARIKAYCE (Amikacin) suspension. The labeled parts include a carrying case (a), a connecting tube (b), the main inhalation device with a display screen (c), a power adapter (d), and a set of batteries (e).*

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Figure (Arikayce 04)

An instructional diagram showing labeled parts of a respiratory inhalation device for ARIKAYCE (Amikacin) suspension. The parts labeled include components like the cap, inhaler body, and mouthpiece, with an inset of an internal mechanism labeled 'k'.*

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Figure (Arikayce 05)

An instructional illustration showing the removal and replacement of two AA batteries in a purple electronic device. The batteries are depicted being inserted or removed, indicated by red arrows pointing away from the device's battery compartment.*

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Figure (Arikayce 06)

Illustration depicting a respiratory inhalation device with a display screen, connected by a cord to a plug-in power adapter. A red arrow labeled 'b.' points towards the connection port where the cord attaches to the device.*

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Figure (Arikayce 07)

An instructional diagram showing two labeled parts of a respiratory inhalation device. Label 'a.' indicates the opening or cap area at the top, and label 'b.' points to the removable lower section of the inhaler device.*

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Figure (Arikayce 08)

An instructional illustration depicting the step to place the mouthpiece cover back onto a respiratory inhalation device. The image uses an orange arrow labeled 'C' to indicate the direction to attach the mouthpiece cover.*

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Figure (Arikayce 09)

An instructional illustration showing a hand holding a small item under running water from a faucet. A clock icon with '10 seconds' indicates the item should be rinsed for 10 seconds, suggesting cleaning or rinsing instructions for device components related to medication administration.*

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Figure (Arikayce 10)

An instructional illustration showing a nebulizer bucket with internal components submerged in water. The image highlights a timer symbol indicating a 5-minute duration, suggesting a cleaning, soaking, or preparation step for the nebulizer device used with inhalation drug products like ARIKAYCE suspension.*

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Figure (Arikayce 11)

An illustration of a clock showing the time at approximately one o'clock with an orange box below it containing the text '5 minutes.' This diagram likely indicates a time duration of 5 minutes.*

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Figure (Arikayce 12)

An instructional illustration showing six disassembled components of a respiratory device or inhalation system, laid out on a cloth or mat. The components include various plastic and mechanical parts likely related to the delivery of ARIKAYCE (amikacin) suspension for inhalation.*

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Figure (Arikayce 13)

An instructional illustration showing hands being rinsed with running water from a faucet, demonstrating proper handwashing technique.*

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Figure (Arikayce 14)

An instructional illustration showing parts of a respiratory inhalation device related to ARIKAYCE Amikacin suspension. It highlights the blue valve component, an aerosol chamber, and valve flaps with visual markers distinguishing correct and incorrect valve flap positions.*

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Figure (Arikayce 15)

An instructional diagram showing parts of an aerosol device used for inhalation. The diagram labels the aerosol head and a blue valve, indicating how these components interact within the device.*

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Figure (Arikayce 15a)

An instructional illustration showing the assembly or usage of a respiratory inhalation device, likely related to administering the ARIKAYCE (Amikacin) suspension. The diagram includes arrows indicating the direction or motion for connecting or operating parts of the inhaler.*

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Figure (Arikayce 16)

An instructional illustration showing an ARIKAYCE inhalation suspension device with a protective cap being removed from the mouthpiece. The depiction highlights the proper opening of the device for inhalation use.*

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Figure (Arikayce 17)

Illustration showing parts A and B of a respiratory inhalation device, including a labeled step (a1) to snap part A onto part a2, with a cord connecting to a base unit labeled B. The device appears intended for use with a suspension medication via respiratory inhalation.*

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Figure (Arikayce 18)

Illustration showing a vial with an orange cap being shaken up and down, accompanied by a clock icon and text instructing to "Shake minimum 10-15 sec." This image likely indicates the requirement to shake the product vial before use.*

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Figure (Arikayce 19)

An instructional illustration showing the top view of a bottle with an orange flip-top cap, highlighting the opening mechanism for the inhalation suspension container.*

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Figure (Arikayce 20)

An instructional illustration showing the step to open a closure on a container by flipping the cap upward and outward. The image likely guides the proper way to open the inhalation suspension container cap.*

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Figure (Arikayce 21)

Illustration showing how to open the cap of a suspension bottle, likely for ARIKAYCE (Amikacin) 590 mg/8.4 mL. The image depicts lifting the cap upwards by rotating the flip-top lid to access the bottle contents for inhalation use.*

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Figure (Arikayce 22)

An instructional illustration showing a close-up of an open bottle with its cap lifted, alongside an arrow indicating the motion to open the cap. The image likely demonstrates how to open the bottle for use.*

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Figure (Arikayce 23)

An illustration showing a hand pouring a liquid suspension from a small bottle into a respiratory inhalation device. The top-left inset shows a close-up of the device's mouthpiece cover with an arrow labeled 'b.' The main image includes an arrow labeled 'a' pointing to where the liquid is poured into the device's reservoir.*

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Figure (Arikayce 24)

An instructional illustration showing the correct assembly and usage of a nebulizer device for respiratory inhalation therapy. It depicts a mouthpiece attached to a chamber with medication inside, connected to a patient wearing a face mask or mouthpiece. The diagram emphasizes proper placement and flow direction for effective inhalation of the suspension medication.*

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Figure (Arikayce 25)

Illustration showing a person holding and using a respiratory inhalation device. The device has a mouthpiece with a blue cover, which the person is placing in their mouth for inhalation. The device appears detailed with a circular component at the top, likely part of the inhalation mechanism.*

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Figure (Arikayce 26)

An illustration of the ARIKAYCE inhalation device, shown in purple with a rectangular screen displaying a checkmark symbol. The device has a connected white mouthpiece tube for delivering the amikacin suspension by respiratory inhalation.*

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Image (Arikayce 28)

Illustration of the LAMIRA Nebulizer System instructions for use, including the eFlow controller device and nebulizer cup. The image indicates the device is for use only with ARIKAYCE (amikacin liposome inhalation suspension) and includes warnings about proper use and safety precautions.*

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Image (Arikayce 29)

A warning label panel with the word 'Warning' displayed prominently inside an orange rectangular box. The panel is designed to alert users about important safety information related to the drug product.*

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Image (Arikayce 30)

ARIKAYCE 590 mg/8.4 mL inhalation suspension packaging with prominent red 'Danger' warning box on the label. Labeler indicated as Insmed Incorporated. This product is a human prescription drug for respiratory use.*

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Image (Arikayce 31)

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Image (Arikayce 32)

An exploded diagram and component layout of the ARIKAYCE respiratory inhalation suspension device by Insmed Incorporated. The image shows the carrying case, controller, connection cord, A/C power supply, and "AA" batteries. It also details the spare handset including the medication cap, medication reservoir, aerosol chamber, spare aerosol head labeled Lamira, blue valve, and mouthpiece, with a close-up highlighting the ARIKAYCE medication reservoir label.*

FDA Label Image

Image (Arikayce 33)

An instructional diagram showing the ARIKAYCE inhalation suspension controller device. The first image shows the battery door with an arrow indicating it should be opened. The second image shows the battery door open with arrows indicating the removal or insertion of three AA batteries into the compartment.*

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Image (Arikayce 34)

Illustration showing a power supply connection to a device with labeled parts including A/C Power Supply, Gray Battery Door, Plug Inlet Port, and Plug Insert. The image demonstrates where to plug the power connector into the device, likely related to ARIKAYCE inhalation suspension usage.*

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Image (Arikayce 35)

A drug warning panel featuring an orange background with a black warning icon and the word 'Warning' in bold black letters. The panel is designed to alert users to important safety information.*

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Image (Arikayce 36)

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Image (Arikayce 37)

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Image (Arikayce 38)

An illustration showing two views of a respiratory inhalation device for ARIKAYCE (amikacin) suspension. The images depict the step of attaching or aligning a component to the inhalation device, indicated by red arrows for guidance.*

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Image (Arikayce 39)

An instructional illustration showing the removal of the cap from a device or container by lifting it upward after a partial rotation, indicated by a red arrow and a red curved arrow. The illustration is labeled 'F-2' in a blue oval.*

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Image (Arikayce 40)

An instructional illustration showing the assembly of a handheld respiratory inhalation device for ARIKAYCE (amikacin) suspension. The diagram depicts a mouthpiece being attached or removed from the main inhaler body, indicated by a red arrow pointing toward the device.*

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Image (Arikayce 41)

An instructional illustration labeled 'F-4' showing a device component with flexible plastic tabs and a removable blue tab piece. The diagram highlights how the flexible plastic tabs interact with the blue tab, likely part of the device's assembly or usage instructions.*

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Image (Arikayce 42)

An instructional diagram showing hands assembling or attaching a component of a respiratory inhalation device. Red arrows indicate direction for proper alignment, with a check mark for correct positioning and an X mark for incorrect handling.*

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Image (Arikayce 43)

An instructional diagram showing three labeled parts of a respiratory device, likely related to ARIKAYCE inhalation suspension. The components include a top section labeled F-6a, a middle section labeled F-6b, and a mouthpiece or inhaler component labeled F-6c, with red arrows indicating the assembly direction.*

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Image (Arikayce 44)

Instructional diagram showing a hand rinsing a device component under running water for 10 seconds. The illustration is likely related to cleaning or maintenance of a respiratory inhalation device.*

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Image (Arikayce 45)

An instructional illustration showing a hand holding a device component under running water from a faucet, demonstrating cleaning or rinsing of the part. This image likely supports instructions for maintenance or use of the ARIKAYCE inhalation suspension device.*

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Image (Arikayce 46)

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Image (Arikayce 47)

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Image (Arikayce 48)

An instructional illustration showing individual components of a respiratory inhalation device kit. The diagram highlights parts likely associated with the administration of ARIKAYCE (Amikacin) suspension for inhalation, labeled as G-3. The components are drawn separately for clarity, including the main inhalation device and detachable pieces.*

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Image (Arikayce 49)

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Image (Arikayce 50)

An instructional illustration showing a close-up of a person's hands under running water from a faucet. The image demonstrates rinsing or washing hands or an object under the water stream.*

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Image (Arikayce 51)

An instructional diagram showing a component of a respiratory inhalation device with a tab indicated for operation or adjustment. The image includes directional arrows suggesting how to move or manipulate the device.*

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Image (Arikayce 52)

An instructional diagram illustrating the proper configuration of the blue valve and valve flaps of an aerosol chamber component used with ARIKAYCE inhalation suspension. The diagram contrasts correct and incorrect valve flap arrangements, highlighting the blue valve and aerosol chamber parts.*

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Image (Arikayce 53)

An instructional illustration showing a close-up of a hand holding a medical device component incorrectly, indicated by a red X over the image. This suggests a demonstration of improper handling related to ARIKAYCE (Amikacin) inhalation suspension usage.*

FDA Label Image

Image (Arikayce 54)

Illustration showing a close-up view of a person holding a small device piece between thumb and index finger, with a magnified inset highlighting the device labeled "Lamira®." The diagram appears to focus on the device's detail or branding feature.*

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Image (Arikayce 55)

An instructional illustration showing a hand operating the top of a medication reservoir with four holes, highlighting flexible plastic tabs. This diagram is likely part of usage instructions for a respiratory inhalation suspension device.*

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Image (Arikayce 56)

An instructional diagram showing a close-up view of a respiratory inhalation device part with an arrow indicating the direction to slide or open a component, likely related to the use or assembly of ARIKAYCE (Amikacin) suspension inhalation drug delivery.*

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Image (Arikayce 57)

An instructional illustration showing a respiratory inhalation device with a blue flap and slot labeled for assembly or use. The diagram highlights how the blue flap fits into the slot on the device, likely indicating a step in preparing or using the ARIKAYCE inhalation suspension device.*

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Image (Arikayce 58)

Illustration showing a two-step assembly process for a respiratory device component. The image demonstrates attaching a mouthpiece piece (labeled H-8a) to the main inhalation device (H-8), securing it by snapping into place as indicated by a red arrow and the label 'SNAP'.*

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Image (Arikayce 59)

An instructional diagram showing a respiratory inhalation device connected by tubing to a circular electronic control unit or nebulizer base, demonstrating assembly or use for inhalation therapy.*

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Image (Arikayce 60)

An instructional illustration showing a vial held at an angle with arrows indicating to invert or shake it. A clock icon in the background suggests waiting or timing in the process. Includes a small oval label I-1.*

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Image (Arikayce 61)

An instructional diagram illustrating the stepwise removal of packaging components from a vial. It shows sequentially removing an orange cap, then a metal ring with metal band, and finally accessing the rubber stopper. The images are labeled I-2 through I-5, demonstrating vial opening preparation steps.*

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Image (Arikayce 62)

Illustration showing a hand adding liquid medication into the medication reservoir of a respiratory inhalation device, demonstrating proper placement of the medication drop.*

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Image (Arikayce 62a)

An instructional illustration showing the disassembly of a component with labels for the inner cap, tab, and tab slot, with arrows indicating the removal direction. The image is likely part of assembly or usage instructions for the ARIKAYCE inhalation suspension device.*

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Image (Arikayce 63)

Illustration showing a hand pressing the on/off button on a respiratory inhalation device with labeled components including the on/off button, status light, and LCD display. The labeled diagram highlights user interface elements of the device for ARIKAYCE inhalation suspension.*

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Image (Arikayce 64)

Two black and white instructional illustrations. The first, labeled 'START SCREEN,' shows the logo for eFlow Technology. The second illustration, labeled 'TREATMENT,' depicts a handheld nebulizer device releasing inhalation mist from its mouthpiece.*

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Image (Arikayce 65)

An instructional illustration showing a person holding a handheld inhalation device near their mouth, with a focus on proper positioning for inhalation use.*

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Image (Arikayce 66)

An instructional diagram showing a person holding and using an inhalation device, likely demonstrating the correct technique for administering ARIKAYCE suspension via inhalation. The image includes a visual cue indicating not to tilt or perform a certain motion, as shown by a red cross mark and an arrow.*

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Image (Arikayce 67)

An instructional illustration showing two states of a device for inhalation. The left panel labeled 'I-9b' displays the device emitting a mist with the indication 'ON - with mist.' The right panel labeled 'I-9c' shows the device without mist and is labeled 'PAUSE - no mist.' This likely guides proper use of ARIKAYCE inhalation suspension.*

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Image (Arikayce 68)

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Image (Arikayce 69)

An instructional illustration showing two steps of handling a medication device cap. The first step (I-10b) demonstrates twisting the cap counterclockwise and lifting it off. The second step (I-10c) shows placing the cap back on and twisting it clockwise to secure it.*

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Image (Arikayce 70)

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Image (Arikayce 71)

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Image (Arikayce 72)

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Image (Arikayce 73)

The image shows a medication label for ARIKAYCE suspension, containing 590 mg of Amikacin in an 8.4 mL inhalation suspension form. The label includes the product name ARIKAYCE prominently and notes it as a respiratory inhalation drug by Insmed Incorporated.*

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Image (Arikayce 74)

An instructional diagram illustrating a handheld device with an inlet and a mouthpiece, likely representing a respiratory inhalation suspension administration device for ARIKAYCE (amikacin) 590 mg/8.4 mL, used in inhalation therapy.*

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Image (Arikayce 75)

Illustration showing a respiratory inhalation device intended for delivering ARIKAYCE (amikacin) suspension. The device includes a mouthpiece, medication chamber, and control panel, indicating use with inhaled suspension medication for respiratory administration.*

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Image (Arikayce 76)

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Image (Arikayce 77)

An instructional illustration showing a device administering a spray or aerosol, likely representing aerosol delivery for inhalation. The image depicts the device producing a dispersed mist or spray toward an indicated direction.*

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Image (Arikayce 78)

An instructional illustration showing the powdered contents of an amikacin inhalation suspension vial being poured into the reservoir of a nebulizer chamber. The drawing depicts the vial positioned above the chamber with powder falling into it, indicating the preparation step before inhalation.*

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Image (Arikayce 79)

An instructional illustration showing a hand turning a circular component labeled 'ON' on a respiratory inhalation device, likely part of the ARIKAYCE suspension delivery system. The diagram focuses on the activation step essential for use.*

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Image (Arikayce 80)

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Image (Arikayce 81)

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Image (Arikayce 82)

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Figure (Arikayce 83)

Illustration showing four labeled components of a medical device or system: a. a rectangular case or container with a hinged lid, b. a circular tubing assembly with a mouthpiece and a protective case, c. a handheld device resembling a remote or inhaler controller, and d. a power adapter or charging device with a cable.*

FDA Label Image

Figure (Arikayce 84)

An instructional diagram showing parts of a respiratory inhalation device for ARIKAYCE (amikacin) suspension. The image illustrates components including a removable cap (e), a medication chamber (f), the main inhalation body (g), a mouthpiece (h), a protective cover (i), and a close-up of an internal valve or mechanism (j). Arrows indicate directions for assembly or use.*

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Figure (Arikayce 85)

Illustration showing how to connect a charger to a handheld electronic device via a USB cable, indicated by a red arrow pointing from the charger plug to the device's charging port.*

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Figure (Arikayce 86)

An instructional illustration showing two labeled parts of a device component, marked as 'a.' and 'b.' with arrows pointing to a top circular section and a lower rectangular compartment respectively, likely part of a respiratory inhalation suspension device.*

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Figure (Arikayce 87)

An instructional diagram showing a hand positioning a respiratory inhalation device with an arrow pointing to a specific part labeled 'C.' The device is depicted partly in blue and white.*

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Figure (Arikayce 88)

Illustration showing a hand holding a nebulizer device part under running water from a faucet, with a clock icon indicating a 10-second duration for rinsing or cleaning.*

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Figure (Arikayce 89)

An instructional illustration showing the cleaning process of a nebulizer cup submerged in water with bubbles. A clock icon indicates a 5-minute duration for soaking or cleaning. The diagram highlights components of the nebulizer inside the container filled with water.*

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Figure (Arikayce 90)

An illustration showing a clock face indicating five minutes with the caption '5 minutes' below it, likely representing a time duration or waiting period.*

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Figure (Arikayce 91)

An illustration showing disassembled components of a nebulizer or inhalation device, including mouthpiece, medication cup, and connecting parts, likely used for respiratory administration of ARIKAYCE suspension (Amikacin). No text or labels are visible on the components.*

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Figure (Arikayce 92)

An instructional illustration showing a hand held under running water from a faucet, demonstrating handwashing or rinsing technique. The water spray is depicted clearly over the hand.*

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Figure (Arikayce 93)

An instructional diagram showing parts of a respiratory inhalation device for ARIKAYCE (Amikacin) suspension. The image highlights the aerosol chamber and two versions of a blue valve component, identifying correct valve flaps configuration and an incorrect valve flap arrangement with a red cross.*

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Figure (Arikayce 94)

An instructional diagram illustrating the components of an inhalation device, specifically showing a hand holding the aerosol head next to a blue valve, indicating how the aerosol head fits onto the valve to assemble the device.*

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Figure (Arikayce 95)

An instructional diagram showing a close-up of an inhalation device with a red arrow pointing to a specific component, indicating a step or direction for use or assembly related to the respiratory suspension product ARIKAYCE (Amikacin).*

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Figure (Arikayce 96)

An instructional illustration showing the assembly of a device with a removable blue and white mouthpiece or cap on the front end. The arrow indicates the mouthpiece being attached or inserted into the main device body.*

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Figure (Arikayce 97)

An instructional diagram showing the connection of a medical device for respiratory inhalation. It features a close-up of a suspension inhaler labeled 'A' with steps marked 'a1' and 'a2' for attaching a component, and a cable connection labeled 'B' linking the device to a handheld electronic unit, likely for monitoring or control.*

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Figure (Arikayce 98)

An instructional illustration showing a small vial with an orange cap and arrows indicating shaking motion, accompanied by text advising to shake the vial for a minimum of 10-15 seconds. This suggests preparation instructions for a medication suspension, likely ARIKAYCE.*

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Figure (Arikayce 99)

An illustration showing the use of a cap removal tool or device on the top of a small bottle, likely representing the opening mechanism for a medications vial or inhalation suspension container, relevant to ARIKAYCE inhalation suspension.*

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Figure (Arikayce 100)

An instructional illustration showing two stages of handling a cap on a bottle or inhalation device. One frame depicts the cap being lifted upwards, and the other depicts the cap being pushed sideways, indicating different ways to open or remove it.*

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Figure (Arikayce 101)

An instructional illustration showing the action of opening a flip-top cap on a small bottle or vial, indicating to lift the cap upward and backward to access the contents inside.*

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Figure (Arikayce 102)

An instructional illustration showing a bottle with its cap being removed by lifting it upwards, indicated by a red arrow. This is likely related to preparation or usage steps for ARIKAYCE suspension, inhalation route.*

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Figure (Arikayce 103)

An instructional illustration showing a hand pouring liquid from a small vial into a device with an open top, labeled with steps 'a.' and 'b.'. The device appears to be a respiratory inhalation tool with a mouthpiece and removable cap being placed after filling.*

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Figure (Arikayce 104)

An instructional illustration showing a cross-sectional view of a respiratory inhalation device used for administering ARIKAYCE suspension. The diagram appears to detail the device components and airflow path for inhalation therapy.*

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Figure (Arikayce 105)

An instructional illustration showing a person holding a handheld inhalation device close to their mouth, preparing to use it. The image emphasizes the proper positioning of the device for respiratory inhalation.*

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Figure (Arikayce 106)

Illustration of the eBase electronic drug administration device, featuring a display screen with a bottle icon and a checkmark. The device is rectangular with a power button icon, a brand label, and a connected tubing at the bottom for respiratory inhalation therapy.*

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Image (Arikayce 107)

Instructional image showing the Lamira Nebulizer System by PARI, including the nebulizer device and an eFlow controller unit. The image includes warnings emphasizing the importance of reading instructions for use and prescribing information for ARIKAYCE (amikacin liposome inhalation suspension) for a limited population. The image notes ARIKAYCE vials are packaged separately and assembly of the nebulizer system is required.*

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Image (Arikayce 108)

An orange rectangular warning label with a black warning symbol on the left and the word 'Warning' in bold black letters on the right. The label is simple and designed to attract attention for safety or caution purposes.*

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Image (Arikayce 109)

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Image (Arikayce 110)

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Image (Arikayce 111)

An exploded view diagram of the components of a respiratory inhalation device for ARIKAYCE (amikacin liposome inhalation suspension). It includes labeled parts such as the carrying case, controller, connection cord, A/C power supply, and a detailed spare handset assembly with medication cap, medication reservoir, aerosol chamber, blue valve, spare aerosol head, and mouthpiece.*

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Image (Arikayce 112)

Illustration showing an A/C power supply connected to a controller device associated with ARIKAYCE (Amikacin) inhalation suspension. The image also depicts a battery status indicator with four bars, representing the device's charge level.*

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Image (Arikayce 113)

Warning label panel in orange with black text and a warning triangle symbol, typically used for highlighting safety or caution information on pharmaceutical product materials.*

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Image (Arikayce 114)

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Image (Arikayce 115)

A warning label banner in bright yellow featuring a black exclamation mark inside a triangle on the left side and the word WARNING in bold black capital letters. This image is typically used as a cautionary alert on product packaging or informational materials.*

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Image (Arikayce 116)

An instructional illustration showing two views of a respiratory inhalation device for ARIKAYCE (Amikacin) suspension. The images depict how to open and interact with parts of the device, indicated by red arrows guiding the user on component removal or adjustment steps.*

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Image (Arikayce 117)

An instructional illustration showing how to open a child-resistant cap on a medication bottle by pressing down and turning the cap counterclockwise. The image is labeled 'F-2' and includes arrows indicating the direction to push and turn the cap.*

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Image (Arikayce 118)

An instructional diagram showing a respiratory inhalation device with a detachable mouthpiece. A red arrow indicates the removal or attachment direction of the blue and white mouthpiece component from the main inhaler body.*

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Image (Arikayce 119)

An instructional diagram showing how to remove and replace a blue tab from a device component with flexible plastic tabs. The steps include pulling the tab out and proper handling of the component, with warnings against incorrect manipulation.*

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Image (Arikayce 120)

An instructional illustration showing three labeled parts of a device with arrows indicating assembly or connection points. The parts are labeled F-6a, F-6b, and F-6c, with arrows pointing downwards toward each subsequent component, suggesting a sequence for assembling or attaching components related to a respiratory inhalation product.*

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Image (Arikayce 121)

An instructional illustration showing a hand holding a device component under a faucet running water for 10 seconds. This likely demonstrates how to clean or rinse the device as part of its usage or maintenance.*

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Image (Arikayce 122)

An instructional diagram showing a detailed view of a component assembly for a respiratory inhalation device container. Key parts are highlighted in blue, including the internal mechanism and a removable cap piece, indicating assembly or usage steps.*

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Image (Arikayce 123)

An instructional illustration showing a hand holding a nebulizer component under a running faucet, rinsing it with water. The image demonstrates cleaning of the nebulizer mouthpiece or part of the inhalation device used with ARIKAYCE suspension (amikacin).*

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Image (Arikayce 124)

An instructional illustration showing three components: a hand holding a device with a cartridge, a power adapter with a USB plug, and a cable with a mouthpiece or mask connector, likely related to the assembly or use of a respiratory inhalation suspension device for ARIKAYCE (amikacin) 590 mg/8.4 mL.*

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Image (Arikayce 125)

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Image (Arikayce 126)

A warning label panel with a black exclamation mark inside a triangle on the left and the word 'Warning' in black text on an orange background to the right. The label is rectangular and emphasizes caution or safety information.*

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Image (Arikayce 127)

An instructional illustration showing components of a respiratory inhalation device, including a mouthpiece, a circular base, and various structural parts likely related to the ARIKAYCE inhalation suspension device assembly or use.*

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Image (Arikayce 128)

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Image (Arikayce 129)

An instructional illustration showing a person rinsing their hand under running water from a faucet. The image highlights handwashing technique, focusing on the palm and fingers beneath the water flow.*

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Image (Arikayce 130)

Illustration depicting a respiratory inhalation device, showing a step where a part labeled 'TAB' is indicated to be moved or manipulated, with arrows demonstrating the direction of movement. The image appears to be an instructional figure related to the use of the ARIKAYCE inhalation suspension device.*

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Image (Arikayce 131)

An instructional diagram showing components of an aerosol chamber for inhalation use, including a blue valve and valve flaps. It distinguishes correct valve flap orientation with a check mark and incorrect orientation with a cross.*

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Image (Arikayce 132)

An instructional illustration showing a finger pressing on a part of a device, with a red X crossing over the image, indicating that pressing at this location is not allowed or incorrect. The label 'H-5a' appears in a blue oval on the left side of the image.*

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Image (Arikayce 133)

An instructional diagram showing a close-up of a finger holding a small component labeled "Lamira". The zoomed-in inset highlights the "Lamira" label on the device, indicating a focus on this part of the inhalation system.*

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Image (Arikayce 134)

An instructional illustration showing a hand holding an ARIKAYCE inhalation suspension device. The diagram highlights the medication reservoir with four holes and flexible plastic tabs, indicating how to open the device for use.*

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Image (Arikayce 135)

Illustration showing a close-up of part of a respiratory inhalation device, with an arrow indicating a motion or direction to open or adjust a component. The image is labeled H-6 in the top left corner.*

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Image (Arikayce 136)

An instructional illustration showing a respiratory inhalation device with an attached medicine tube labeled with a blue flap and a slot. Arrows indicate the position and interaction of these components, likely demonstrating preparation or use of the inhalation suspension.*

FDA Label Image

Image (Arikayce 137)

An instructional diagram showing the attachment of a component labeled H-8a to a device labeled H-8, followed by a step to snap the connector labeled H-8b into place, demonstrating part assembly or connection procedure.*

FDA Label Image

Image (Arikayce 138)

An instructional diagram showing a respiratory inhalation device connected by a tube to an electronic module, which has a port for a USB cable connection. The image highlights two parts labeled H-9 and H-9a, indicating the device and the USB connection, respectively.*

FDA Label Image

Image (Arikayce 139)

An instructional illustration showing a small bottle with an orange cap and arrows indicating upward and downward movement, positioned next to a clock face, suggesting timing or shaking instructions for the liquid inside.*

FDA Label Image

Image (Arikayce 140)

An instructional diagram showing sequential steps to open a bottle with a tamper-evident seal. It illustrates removing the orange cap, lifting the metal ring, peeling back a metal band, and then accessing a rubber stopper to open the bottle.*

FDA Label Image

Image (Arikayce 141)

An instructional line drawing showing a hand holding a small vial above a medication reservoir of a nebulizer device. A droplet is depicted falling into the reservoir, indicating how to add medication to the device for inhalation therapy.*

FDA Label Image

Image (Arikayce 142)

An instructional diagram showing the parts of a cap and how to align and place it onto a container. Labels identify the inner cap, tab, and tab slot with directional arrows indicating the motion for proper assembly or closing.*

FDA Label Image

Image (Arikayce 143)

An instructional diagram showing a hand holding a respiratory inhalation device with an on/off button labeled 'a'. The device has an LCD display and shows the eflow technology start screen. A cord is connected at the bottom of the device.*

FDA Label Image

Image (Arikayce 144)

Two black and white instructional illustrations showing usage steps for ARIKAYCE inhalation suspension. Both depict a device part resembling a mouthpiece followed by different symbols. The left image shows the mouthpiece and the number 3. The right image shows the mouthpiece with dots and an arrow next to a pause symbol.*

FDA Label Image

Image (Arikayce 145)

Illustration showing a person holding and using a handheld device, likely a nebulizer or inhalation device, for respiratory drug administration. The device is held near the mouth, demonstrating the proper technique for inhalation.*

FDA Label Image

Image (Arikayce 146)

An illustration showing how to hold a respiratory inhalation device near the mouth. The image includes a red X marking indicating an incorrect angle to hold the inhaler. It is likely an instructional graphic related to the proper use of ARIKAYCE inhalation suspension.*

FDA Label Image

Image (Arikayce 147)

An instructional diagram showing two states of a device for ARIKAYCE suspension inhalation: 'ON - with mist' indicating active aerosol mist generation, and 'PAUSE - no mist' indicating a paused state with no mist. Each state is represented by a small device icon with mist dots and corresponding control bar icons.*

FDA Label Image

Image (Arikayce 148)

Illustration showing a device with a nozzle tip icon and a checkmark next to it, accompanied by a battery indicator and a power button symbol beneath, likely representing a device readiness or status indicator for administration.*

FDA Label Image

Image (Arikayce 149)

An instructional diagram showing two stepwise illustrations labeled I-10b and I-10c. Both depict how to open a specific cap by lifting and rotating it counterclockwise from a container or device, likely related to preparation or administration of an inhalation suspension.*

FDA Label Image

Image (Arikayce 150)

An instructional illustration showing a hand holding a device, likely a nebulizer or inhalation device, with a finger pressing a button. The device has a clear window and a control panel area, indicating it is used for inhalation of medication, consistent with respiratory drug delivery.*

FDA Label Image

Image (Arikayce 151)

An instructional diagram illustrating eFlow Technology operation steps for a respiratory suspension device. It shows pressing and holding the ON/OFF button until a settings screen with gears icon appears, then releasing the button to reach a screen with a speaker icon, battery, and power button symbol.*

FDA Label Image

Image (Arikayce 152)

An instructional diagram showing three speaker icon states on a device screen related to ARIKAYCE inhalation suspension use: Default with full signal tones, Reduced signal tones with a smaller sound icon, and All signal tones OFF with a speaker and a cross symbol. Each state is labeled and includes a battery and power button graphic below.*

FDA Label Image

Image (Arikayce 152a)

An illustration showing a device screen with a speaker volume icon and a check mark, indicating sound settings or audio confirmation. The image includes a battery icon and a power button icon below the screen, likely representing a powered inhalation device display panel.*

FDA Label Image

Image (Arikayce 153)

This instructional diagram shows three screen display states of a medical device interface related to ARIKAYCE inhalation suspension. Each screen includes a sun icon indicating backlight status: Default with a central dot, Backlight always ON with a bright sun, and Backlight always OFF with a dark sun. Battery and power button icons are also visible below the displays.*

FDA Label Image

Image (Arikayce 153a)

A digital illustration of a device screen with a sun icon in the center, likely indicating light or brightness settings, accompanied by a checkmark in the top-right corner. The bottom left shows a battery icon and the center features a circular button or indicator.*

FDA Label Image

Image (Arikayce 154)

FDA Label Image

Image (Arikayce 155)

A black and white instructional diagram showing a vial or ampule with a curved arrow pointing downward toward a syringe or dropper, alongside the number 3, indicating a step or sequence in a usage or preparation process.*

FDA Label Image

Image (Arikayce 156)

An instructional diagram showing the proper way to operate or use a device by pressing a central control button, with arrows indicating the direction or process flow. This illustration may relate to the administration or use of the ARIKAYCE inhalation suspension device.*

FDA Label Image

Image (Arikayce 157)

An instructional illustration showing an ampule with a checkmark next to it, indicating the correct or approved use or selection of the ampule. The image includes a small icon and a slider bar at the bottom, possibly representing a step or status indicator.*

FDA Label Image

Image (Arikayce 158)

An instructional diagram showing a vial or ampule and a 'pause' symbol, likely indicating a step in the preparation or administration process of ARIKAYCE (amikacin) suspension for respiratory inhalation.*

FDA Label Image

Image (Arikayce 159)

An instructional illustration showing a vial held horizontally with a cap on one end and an arrow indicating twisting it open by turning the cap counterclockwise.*

FDA Label Image

Image (Arikayce 160)

An instructional diagram showing the assembly or use of a device, including a container and a syringe tipped with a nozzle. The illustration appears to demonstrate the connection or attachment process of the components for a respiratory inhalation suspension.*

FDA Label Image

Image (Arikayce 161)

An instructional illustration showing a vial connected to a syringe with a plunger. The image includes arrows indicating the direction of fluid flow from the vial to the syringe and a caution triangle symbol, likely conveying a warning or careful handling instruction.*

FDA Label Image

Image (Arikayce 162)

An instructional diagram showing a low battery icon inside a rectangular screen with an exclamation warning symbol in the upper right corner, likely indicating a low or depleted battery status on an electronic device.*

FDA Label Image

Image (Arikayce 163)

FDA Label Image

Image (Arikayce 164)

FDA Label Image

Image (Arikayce 165)

An instructional diagram showing a device mouthpiece and an hourglass icon, likely indicating timing or duration for inhalation use. The image appears to guide proper respiratory administration technique or timing for a suspension inhalation product.*

FDA Label Image

Image (Arikayce 166)

Illustration of a respiratory inhalation device labeled 'easycare,' showing a side view of the inhaler with a mouthpiece and trigger mechanism. No text related to drug information is present.*

FDA Label Image

Principal Display Panel (8.4 mL Vial Carton)

ARIKAYCE 590 mg/8.4 mL suspension for inhalation, containing amikacin liposome, packaged in 28 sterile unit-dose vials. The label shows the product name, strength, dosage form, quantity, and manufacturer Insmed Incorporated. It includes instructions for storage and a patient support phone number, highlighting its use for oral inhalation only. The label also features the NDC 71558-590-28 and a purple and orange color scheme.*

* 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.