Tofacitinib Solution
Product Images NDC 0054-0821

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Tofacitinib Solution (NDC 0054-0821). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Figure 01 (Figure 1)

This text provides information about intrinsic factors such as weight, age, gender, race, renal impairment, hepatic impairment, PK (pharmacokinetics), AUC (area under the curve), Cmax (maximum plasma concentration), and ratios with 90% confidence intervals. It includes data points related to different parameters and conditions for pharmacokinetic evaluations.*

FDA Label Image

Figure 02 (Figure 2)

This document provides information on drugs like Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, and Metformin. It includes data related to their pharmacokinetics (PK) such as AUC and Cmax. Ratios and 90% confidence intervals are also mentioned in the text, aiding in the evaluation of the drugs mentioned.*

FDA Label Image

Figure 03 (Figure 3)

FDA Label Image

Figure-4.jpg (Figure 4)

This text discusses response rates for a study comparing treatment with a drug vs. placebo over 3 months, with non-responder imputation method used for handling dropouts. Patients were considered failures if they withdrew from the study or did not show at least a 20% improvement in joint counts at Month 3.*

FDA Label Image

Figure-5.jpg (Figure 5)

FDA Label Image

Figure-6.jpg (Figure 6)

FDA Label Image

Figure-7.jpg (Figure 7)

The text provides data on the occurrence of disease flare in patients taking Tofacitinib 5 mg BID compared to those taking a placebo. The percentage of disease flare is shown at specific time points (Week 18, Week 20, and Week 44) with statistical significance indicated by the p-value.*

FDA Label Image

Ifu-image-step-00 (Ifu Figure 1)

This is a guide for administering oral medication using a syringe and a press-in bottle adapter. The text outlines the process of assembling the syringe with the adapter and mentions the ribbed end of the press-in plunger for ease of use. This information can be helpful for accurately dosing oral medications.*

FDA Label Image

Ifu-image-step-09 (Ifu Figure 10)

FDA Label Image

Ifu-image-step-10 (Ifu Figure 11)

FDA Label Image

Ifu-image-step-11 (Ifu Figure 12)

FDA Label Image

Ifu-image-step-01 (Ifu Figure 2)

FDA Label Image

Ifu-image-step-02 (Ifu Figure 3)

FDA Label Image

Ifu-image-step-03 (Ifu Figure 4)

FDA Label Image

Ifu-image-step-04 (Ifu Figure 5)

FDA Label Image

Ifu-image-step-05 (Ifu Figure 6)

FDA Label Image

Ifu-image-step-06 (Ifu Figure 7)

FDA Label Image

Ifu-image-step-07 (Ifu Figure 8)

FDA Label Image

Ifu-image-step-08 (Ifu Figure 9)

FDA Label Image

Structure-formula.jpg (Image 01)

FDA Label Image

Tofacitinib-os-bottle-label-image (Tofacitinib Os Bottle Label Image)

This text is a label for a medication called Tofacitinib in oral solution form. The recommended storage conditions are indicated, and it mentions the need to dispense a Medication Guide to each patient. The concentration of the solution is provided, along with instructions on how to use a dosing syringe. The manufacturer and distributor details are also given.*

FDA Label Image

Tofacitinib-os-folding-carton-image (Tofacitinib Os Folding Carton Image)

This text provides information on Tofacitinib oral solution including storage instructions, recommended dosage, expiration date, manufacturer details, and distribution information. It also mentions the importance of using the original bottle and carton to protect the solution from light. The text includes details on the dosing syringes and adapter. Additionally, there is a reference to a Medication Guide that should be dispensed with the solution.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.