Lazanda
Product Images NDC 71500-110
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Lazanda (NDC 71500-110). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by West Therapeutic Development 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.
Product Images & Figures Index
Clin Stud Fig 2 (Clinical Studies Figure 2)
Lazanda Titration Process (Lazanda Titration Process)
This text provides instructions for a titration process for the medication Lazanda, for pain management. The process involves starting with a 100-mcg dose, administering one spray in one nostril. The patient is instructed to wait at least two hours before using the medication again for the next pain episode. After each dose, the patient is to assess whether pain relief was adequate after 30 minutes. If yes, the patient is to use the same dose for the next pain episode. If not, the patient is to increase the dose for the next pain episode following the titration steps described above until an adequate successful dose is determined.*
Principal Display Panel (100 mcg carton)
This is a description of Lazanda, a fentanyl nasal spray used for breakthrough pain relief in adults who are already receiving opioid therapy. It is administered through the nose using a spray and comes in a child-resistant container with 8 sprays. Each spray delivers 100 microliters of solution containing fentanyl citrate equivalent to 100 mcg fentanyl base. The patients or their caregiver must read the enclosed medication guide to ensure safe use of the product. Lazanda is available only through a restricted distribution program called the TIRF REMS Access program. It must be stored in a child-resistant container at all times, and patients should be advised about maximum dosing during a single breakthrough pain episode. The inactive ingredients include water, mannitol, pectin, sucrose, and phenylethyl alcohol. Any patient or caregiver with questions about Lazanda should contact the drug manufacturer or their healthcare provider.*
Principal Display Panel (300 mcg)
This is a medication guide for Lazanda, a nasal spray containing fentanyl citrate for the management of breakthrough cancer pain in patients who are already using opioids. The medication is only available through a restricted distribution program called TIRF REMS. Each bottle of the medication contains 8 sprays, with each spray delivering 100 microliters of solution containing 300 mcg fentanyl base. The medication requires safe usage, and patients and caregivers must read the enclosed Medication Guide for important warnings and directions. The medication is for nasal administration only, and each bottle delivers 8 full sprays. The product must be stored at up to 77°F, and patients must be tolerant to around-the-clock opioid therapy for safe usage. The patient must read the enclosed medication guide before use, and each spray contains inactive ingredients like water, mannitol, pectin, sucrose, phenylethyl alcohol, propylparaben, and sodium hydroxide for pH adjustment.*
Principal Display Panel (400 mcg carton)
This is a medication guide for Lazanda Fentanyl Nasal Spray, a narcotic pain medicine used to manage breakthrough pain in adults with cancer who are already receiving opioid therapy. The product is delivered using a nasal spray and each bottle contains 8 full sprays, each spray delivers 100 microliters of solution, and each 100 microliter spray contains fentanyl citrate equivalent to 400 mcg fentanyl base. The medication guide must be read by the patient and caregivers before using the product, and the product must be stored at up to 77°F (25°C) in a child-resistant container. Lazanda is only available through a restricted distribution program called the TIRF REMS Access program. For more information about the product, call 1-866-822-1483, or visit the website www.TIRFREMSaccess.com.*
Principal Display Panel (100 mcg)
This a label for a container of Lazanda® spray which contains 100 mg of fentanyl. The container is child-resistant and must be returned after use. The label also contains information about distribution, lot number, expiration date, barcode, artwork cycles, and color matching. No die is used for printing.*
Principal Display Panel (300 mcg)
This text contains product information for Roxly, which is distributed by West Therapeutic Development, LLC. It includes a caution to return the product to a child-resistant container after use. There are also details about approval codes, barcodes, and artwork cycles. The text notes that the artwork is not proofread and that the die does not print.*
Principal Display Panel (400 mcg)
Lazanda is a fentanyl nasal spray for pain management that is distributed by West Therapeutic Development, LLC. The container has child-resistant features, and the label includes information on lot, expiration date, and size. The product comes with an approval requirement, and the barcode is for internal quality control purposes only. The artwork cycle is not proofread, so customers are advised to review it before authorizing Nosco to proceed to final proofing. The die does not print.*
Lazanda Structure (Lazanda Structure)
The text appears to be a chemical formula or structure. It consists of the elements carbon (C), hydrogen(H), and oxygen (O) with functional groups carboxylic acid (-COOH) and a hydroxyl group (-OH) connected to two of the carbon atoms. It is not clear what the context or specific compound this formula represents.*
Med Guide Fig 1 (Med Guide Fig 1)
Med Guide Fig 2 (Med Guide Fig 2)
Med Guide Fig 7 (Med Guide Fig 7)
This text provides information on what to do if you lose the pouch containing medication, instructions on how to order a replacement pouch and continue using Lazanda, and a reference to the Instructions for Use section of the Medication Guide. The Medication Guide has been approved by the U.S. Food and Drug Administration and includes details about preparing Lazanda for use. Lazanda® is a registered trademark of West Therapeutic Development, LLC.*
Medguide Page 3 (Medguide 3)
Lazanda is a prescription medication that contains fentanyl citrate as an active ingredient along with inactive ingredients such as mannitol, pectin, phenylethyl alcohol, propylparaben, sucrose, and water. It is crucial to read the medication guide before taking Lazanda, which provides instructions on how to use and dispose of it properly. Each Lazanda pack has a medication guide, a disposal pouch, and three child-resistant containers holding one bottle of Lazanda. To use a new bottle of Lazanda, one needs to prime it by following the instructions given in the medication guide. It is also imperative to store the Lazanda bottle in its child-resistant container and keep the cardboard box for safekeeping.*
Medguide Page 4 (Medguide 4)
This is a set of instructions for using Lazanda, a medication in spray form. The instructions include details on how to prepare the bottle for use, how to test that it is ready for use, and how to store it afterwards. There are also instructions for re-priming the bottle if it has not been used for more than 5 days. The text is accompanied by several illustrations.*
Medguide Page 5 (Medguide 5)
This text provides instructions on how to use Lazanda, a nasal spray medication. It includes steps for preparing the spray, administration techniques, and how to dispose of it when no longer needed. The guide explains the importance of not overusing medication from one bottle and how to store it in a child-resistant container. It also mentions how to avoid blowing your nose for a certain period after administration.*
Medguide Page 6 (Medguide 6)
This text provides instructions on how to properly dispose of the medication called Lazanda. Patients should empty all the remaining medicine into a pouch to protect others, particularly children, from harm. If the counting window displays a number other than 8, there are still doses left in the bottle. Patients must empty remaining doses of Lazanda into the pouch by using the provided grips. After emptying the bottle into the pouch, users will seal both items and dispose of them in the trash. If needed, patients may call for assistance with the disposal process.*
Principal Display Panel (pouch)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.