Label: MODULIS FOR CATS- cyclosporine solution

  • NDC Code(s): 13744-536-01, 13744-536-02
  • Packager: Ceva Sante Animale
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated August 5, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION
    Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
  • DESCRIPTION
    Description: MODULIS® for Cats (cyclosporine oral solution) USP MODIFIED is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the ...
  • VETERINARY INDICATIONS
    Indication: MODULIS® for Cats is indicated for the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and ...
  • DOSAGE & ADMINISTRATION
    Dosage and Administration: Always provide the Instructions for Assembling the Dispensing System and Preparing a Dose of MODULIS® for Cats and the Information for Cat Owners with ...
  • CONTRAINDICATIONS(What is this?)
    Contraindications: Do not use in cats with a history of malignant disorders or suspected malignancy. Do not use in cats infected with feline leukemia virus (FeLV) or feline immunodeficiency virus ...
  • WARNINGS
    Warnings: MODULIS® for Cats is a systemic immunosuppressant that may increase the susceptibility to infection and the development of neoplasia. One of 205 field study cats died of the effusive ...
  • SPL UNCLASSIFIED SECTION
    Human Warnings: Not for human use. Keep this and all drugs out of reach of children. For use only in cats.
  • SPL UNCLASSIFIED SECTION
    Special precautions to be taken when administering MODULIS® for Cats: Do not eat, drink, smoke, or use smokeless tobacco while handling MODULIS® for Cats. Wash hands after administration. In case ...
  • PRECAUTIONS
    Precautions: The safety and effectiveness of MODULIS® for Cats has not been established in cats less than 6 months of age or less than 3 lbs (1.4 kg) body weight. MODULIS® for Cats is not for use ...
  • ADVERSE REACTIONS
    Adverse Reactions: The clinical safety of cyclosporine was assessed in a masked, controlled 6-week field study followed by a 12-week open-labeled dose-tapering field study. In these two field ...
  • SPL UNCLASSIFIED SECTION
    Contact Information: To report suspected adverse events, for technical assistance or to obtain a copy of the safety data sheet (SDS), contact Ceva Animal Health at 1-800-999-0297 or www.ceva.us ...
  • INFORMATION FOR OWNERS/CAREGIVERS
    Information for Cat Owners: Owners should be advised to discontinue MODULIS® for Cats and contact their veterinarian in case of signs of serious illness and/or persistent, progressive weight ...
  • CLINICAL PHARMACOLOGY
    Clinical Pharmacology: Cyclosporine is an immunosuppressive agent that has been shown to work via suppression of T-helper and T-suppressor cells and inhibition of interleukin-2. It does not ...
  • SUMMARY OF SAFETY AND EFFECTIVENESS
    Effectiveness: A masked, controlled field study was conducted at 24 sites from various geographic locations in the United States and Canada. In this study, 217 client-owned cats with clinical ...
  • SPL UNCLASSIFIED SECTION
    Animal Safety: In a 6-month safety study, forty (20 male and 20 female) 6-month old cats were randomized into 5 treatment groups and administered 0, 8, 16, 24 or 40 mg/kg/day cyclosporine (0, 1 ...
  • STORAGE AND HANDLING
    Storage Information: MODULIS® for Cats should only be dispensed in the original container and stored at controlled room temperature between 59 and 77°F (15-25°C). Modulis® for Cats does not ...
  • HOW SUPPLIED
    How Supplied: MODULIS® for Cats (cyclosporine oral solution) USP MODIFIED is supplied in glass amber bottles of 4.7, 15, and 30 mL at 100 mg/mL. A dispensing system is included (See Instructions ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for: Ceva Animal Health, LLC. Lenexa, KS 66215 - Approved by FDA under ANADA # 200-744 - MODULIS® is a registered trademark of Ceva Santé Animale S.A. REV:10/23 - F44010N 08-A1-v1 - Made in ...
  • PATIENT PACKAGE INSERT
    Instructions for Assembling the Dispensing System and Preparing a Dose of MODULIS® for Cats (cyclosporine oral solution) USP MODIFIED - Assembling the Dispensing System - The dispensing ...
  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton(What is this?)
    Modulis® for Cats - (cyclosporine oral solution) USP MODIFIED - 100 mg/mL - For oral use in cats only - Caution: Federal law restricts this drug to use by or - on the order of a licensed veterinarian. Net ...
  • INGREDIENTS AND APPEARANCE
    Product Information