Invega Hafyera Injection, Suspension, Extended Release
Product Images NDC 50458-611

Product Visual Gallery

This gallery contains 52 technical images submitted to the FDA as part of the official labeling for Invega Hafyera (NDC 50458-611). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen Pharmaceuticals, Inc, 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

Image (Invega 01)

Illustration showing a hand shaking a syringe by moving it up and down. The image uses arrows to indicate the shaking motion, likely demonstrating how to properly mix the injection suspension before use.*

FDA Label Image

Image (Invega 02)

FDA Label Image

Image (Invega 03)

An instructional diagram of a syringe showing labeled parts including the syringe tip cap, luer connection, finger flange, and plunger. The syringe is depicted upright with labels pointing to each component.*

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Image (Invega 04)

FDA Label Image

Image (Invega 05)

Illustration diagram showing a syringe with labeled parts: yellow hub, needle sheath, and needle pouch. The image likely serves as an instructional graphic for the injection device accompanying INVEGA HAFYERA (paliperidone palmitate) extended release suspension for intramuscular injection.*

FDA Label Image

Image (Invega 06)

An instructional illustration showing a hand holding and manipulating a syringe, demonstrating a preparation step likely related to the use of an injection product such as INVEGA HAFYERA.*

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Image (Invega 07)

A text panel instructing to shake the INVEGA HAFYERA injection syringe very fast with the tip cap pointing up for at least 30 seconds if more than 5 minutes pass before injection, to resuspend the product.*

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Image (Invega 08)

An instructional illustration demonstrating how to use a syringe. It shows hands holding a syringe with a 15-second wait indicated by a clock icon and arrows, followed by a resting step, repeated on two sides. The image suggests a shaking or mixing action for a suspension injection, relevant for products like INVEGA HAFYERA.*

FDA Label Image

Image (Invega 09)

An illustration showing a close-up of a vial held by a hand, with the vial label partially visible and containing liquid. The vial appears to be prepared for a suspension injection, consistent with an extended-release formulation.*

FDA Label Image

Image (Invega 10)

INVEGA HAFYERA 1092 mg/3.5 mL injection vial label showing a clear glass vial with a liquid suspension inside. The label contains essential product information including the proprietary name, strength, dosage form as extended-release suspension for intramuscular use, and the labeler Janssen Pharmaceuticals, Inc.*

FDA Label Image

Image (Invega 11)

The image shows a close-up of a clear glass vial containing a white suspension. The vial is sealed with a silver metallic cap. This vial likely contains INVEGA HAFYERA injection, suspension, extended release, which is available in strengths including 1092 mg/3.5 mL and 1560 mg/5 mL, manufactured by Janssen Pharmaceuticals, Inc.*

FDA Label Image

Image (Invega 12)

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Image (Invega 13)

An instructional illustration showing two hands peeling back a protective cover or seal from a small object, likely a component related to a pharmaceutical injection device or packaging.*

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Image (Invega 14)

An instructional illustration showing a hand holding a syringe, with arrows indicating a twisting motion at the top of the syringe and an upward movement, likely demonstrating the steps to prepare the injection for use.*

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Image (Invega 15)

An instructional warning icon with text advising to use only the needle included in the kit. The graphic features a caution symbol above the message "Only use the needle included in this kit."*

FDA Label Image

Image (Invega 16)

An instructional illustration showing a hand holding a syringe labeled INVEGA HAFYERA (paliperidone palmitate) injection, suspension, extended-release, being prepared for use. The image emphasizes the step of pressing or pulling the plunger downward, indicating preparation for injection by the intramuscular route.*

FDA Label Image

Image (Invega 17)

Illustration showing hands preparing an extended-release injection suspension syringe, with one hand holding the syringe and another hand pulling a protective cap or plunger upwards. The image relates to the preparation of INVEGA HAFYERA (paliperidone palmitate) intramuscular injection.*

FDA Label Image

Image (Invega 18)

Illustration showing the gluteal intramuscular injection site on the buttocks. The diagram depicts the back view of a human figure with an arrow indicating the location for a gluteal injection.*

FDA Label Image

Image (Invega 19)

An instructional illustration showing a hand holding a syringe with a needle cap being pulled off, indicated by an upward-pointing arrow above the cap. This likely demonstrates part of the preparation process for administering an injection, consistent with the INVEGA HAFYERA extended-release suspension injection.*

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Image (Invega 20)

A text panel containing an instruction for intramuscular injection: verifying that the entire content of the syringe has been injected while the needle remains in the gluteal muscle.*

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Image (Invega 21)

An instructional illustration showing a hand holding a syringe with a plunger. The image emphasizes confirming the correct positioning of the plunger with a close-up inset and includes a 30-second timer icon. The text 'CONFIRM!' is visible, indicating an important step in the injection preparation process.*

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Image (Invega 22)

An instructional diagram showing a hand holding a syringe with a needle cap being removed by pulling it off, indicated by an arrow and an inset circle showing a close-up of the cap being clicked off the syringe tip.*

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Image (Invega 23)

An instructional illustration showing proper disposal of a syringe into a biohazard sharps container on the top half, and an intramuscular injection being administered in the lower half, depicting proper injection technique for an intramuscular drug suspension.*

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Chemical Structure (Invega 24)

Chemical structure of paliperidone palmitate, the active ingredient in INVEGA HAFYERA injection suspension extended release.*

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Figure 1 (Invega 25)

A pharmacokinetic chart titled 'Effect of Other Drugs on INVEGA HAFYERA Pharmacokinetics' showing fold changes and 90% confidence intervals for AUC and Cmax. It compares the effects of three drugs: paroxetine (CYP2D6 inhibitor), carbamazepine (CYP3A4 inducer), and divalproex sodium ER, indicating their impact on INVEGA HAFYERA relative to a reference without interacting drug.*

FDA Label Image

Figure 2 (Invega 26)

A chart titled 'Effect of INVEGA HAFYERA on Pharmacokinetics of Other Drugs' showing fold change and 90% confidence intervals for Divalproex Sodium ER. The graph plots change relative to a reference (without interacting drug) on the x-axis against pharmacokinetic parameters AUC and Cmax on the y-axis, with values near 1 indicating minimal change.*

FDA Label Image

Figure 3 (Invega 27)

A horizontal bar chart showing the effect of intrinsic factors on INVEGA HAFYERA pharmacokinetics, measuring fold change and 90% confidence intervals. Factors include renal impairment (mild, moderate, severe vs. normal), hepatic impairment (moderate vs. normal), and age groups (18-64 vs. >65 years old), with pharmacokinetic parameters AUC and Cmax plotted against change relative to reference.*

FDA Label Image

Figure 4 (Invega 28)

A Kaplan-Meier survival curve chart showing the percent of subjects with relapse over time (days since randomization) for INVEGA HAFYERA (dashed line, N=478) and PP3M (solid line, N=224). The x-axis represents time in days up to 364, and the y-axis represents the percent relapse, ranging from 0% to 50%. Below the chart, a table displays the number of subjects at risk at various time points for both INVEGA HAFYERA and PP3M groups.*

FDA Label Image

Image (Invega 29)

Packaging label for INVEGA HAFYERA 1,092 mg/3.5 mL extended-release injectable suspension, containing paliperidone palmitate. The label indicates a single-dose prefilled syringe and needle for gluteal intramuscular injection, with storage instructions and shake directions. The product is from Janssen Pharmaceuticals, Inc, and dosage administration is every 6 months.*

FDA Label Image

Image (Invega 30)

Packaging label for INVEGA HAFYERA 1560 mg/5 mL extended-release injectable suspension containing paliperidone palmitate. The product is a single-dose prefilled syringe for gluteal intramuscular injection, supplied by Janssen Pharmaceuticals, Inc. The label includes dosage and storage instructions, a barcode, and usage guidance indicating administration every 6 months with specific syringe shaking instructions.*

FDA Label Image

Image (Invega 31)

A text panel titled 'Preparation' explaining that INVEGA HAFYERA requires longer and faster shaking than once-a-month paliperidone palmitate extended-release injectable suspension, with INVEGA SUSTENNA given as an example.*

FDA Label Image

Image (Invega 32)

An illustration of a prefilled syringe for INVEGA HAFYERA injection, suspension, extended release. The syringe diagram labels the syringe tip cap, luer connection, finger flange, and plunger, showing the main components of the intramuscular injection device.*

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Image (Invega 33)

Illustration labeled 'Thin Wall Safety Needle' showing a 20 gauge by 1½ inch needle with a yellow hub. The diagram highlights the needle sheath and needle pouch, emphasizing that only the included needle should be used with the kit.*

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Image (Invega 34)

An instructional diagram showing a hand holding a syringe with the tip cap pointing upward. The illustration highlights the correct orientation for handling the syringe tip cap before use.*

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Image (Invega 35)

Instructional illustration showing the preparation steps for INVEGA HAFYERA injection, suspension, extended release. The diagram depicts holding and inverting the syringe with rest periods of 15 seconds, indicating specific mixing or suspension steps before administration.*

FDA Label Image

Image (Invega 36)

A text panel providing instructions for handling the medication, specifically advising to shake the syringe very fast with the tip cap pointing up if more than 5 minutes pass before injection. The text is in English and emphasizes proper preparation technique.*

FDA Label Image

Image (Invega 37)

An illustration showing a close-up of a vial labeled for injection, depicting the proper connection or placement of a needle or other device at the vial's rubber stopper. This image likely demonstrates a step in preparing the INVEGA HAFYERA injection, suspension, extended release for intramuscular use.*

FDA Label Image

Image (Invega 38)

Illustration showing a close-up view of a vial with a milky suspension inside, labeled 'Mixed well,' indicating proper mixing of INVEGA HAFYERA injection suspension before use.*

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Image (Invega 39)

An image showing a vial of INVEGA HAFYERA injection suspension with visible separation indicating the medication is not mixed well. The illustration highlights the importance of proper suspension mixing before administration.*

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Image (Invega 40)

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Image (Invega 41)

An instructional illustration showing hands peeling back a protective seal or cover from a medical device or container cap with a blue arrow indicating the direction to pull.*

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Image (Invega 42)

An instructional illustration showing how to prepare an injection. The top half depicts removing a cap by twisting and pulling it upward from a syringe-like device. The bottom half shows attaching or securing the syringe to a vial by twisting the connection.*

FDA Label Image

Image (Invega 43)

A warning label panel with a yellow triangular caution symbol and the text 'Only use the needle Included In this kit.' advising exclusive use of the provided needle for the product.*

FDA Label Image

Image (Invega 44)

An instructional diagram showing hands holding a syringe and pulling down the plunger, indicating preparation or administration technique for an injection. This illustration is likely related to the use of INVEGA HAFYERA, an extended-release suspension injection.*

FDA Label Image

Image (Invega 45)

An instructional illustration showing hands preparing a syringe by pulling back the plunger, with a blue arrow indicating the direction of movement. The image likely demonstrates part of the process for preparing an extended-release intramuscular injection.*

FDA Label Image

Image (Invega 46)

An anatomical illustration showing the recommended site for intramuscular injection in the gluteal area of the buttocks. The diagram highlights the upper outer quadrant on both sides, indicated in blue, with an arrow pointing to the gluteal injection site.*

FDA Label Image

Image (Invega 47)

An instructional illustration showing a hand holding a syringe with a needle attached, and an upward blue arrow indicating the direction for removing or pulling the needle cap or cover off the syringe. This likely relates to preparation or administration steps for an injection.*

FDA Label Image

Image (Invega 48)

Instructional illustration showing a hand holding a syringe for an injection. The image highlights waiting 30 seconds and confirms the syringe plunger position through a magnified view, indicating a step for proper administration technique.*

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Image (Invega 49)

An instructional illustration showing a hand holding a syringe and pressing down on the cap with a thumb. A callout circle displays the syringe cap clicking as it is detached.*

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Image (Invega 50)

An instructional illustration showing two steps: inserting a needle into a sharps disposal container for safe disposal, and cleaning the injection site on the skin with an alcohol swab or cotton ball. The images demonstrate proper injection aftercare procedures.*

FDA Label Image

Principal Display Panel (3.5 mL Syringe Carton)

Packaging label for INVEGA HAFYERA 1092 mg/3.5 mL extended-release injectable suspension. The label states the product contains paliperidone palmitate for gluteal intramuscular injection, includes a single-dose prefilled syringe, and directions to shake the syringe with the tip pointing up very fast for 15 seconds twice before use. The label is primarily blue and white with yellow highlights and includes storage instructions and manufacturer information for Janssen Pharmaceuticals, Inc.*

FDA Label Image

Principal Display Panel (5 mL Syringe Carton)

Packaging label for INVEGA HAFYERA 1,560 mg/5 mL extended-release injectable suspension containing paliperidone palmitate. The label indicates a single-dose prefilled syringe for gluteal intramuscular injection only, manufactured by Janssen Pharmaceuticals, Inc. It includes dosing and storage instructions, syringe shaking directions, and a barcode.*

* 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.