STELFONTA 1 Mg/mL: Product Information (Page 4 of 4)

STORAGE INFORMATION

Store STELFONTA vials refrigerated at 2°C to 8°C (35°F to 46°F).

Do not freeze.

Keep the vial in the carton at all times to protect the vial from light.

For single use only.

Dispose of any unused product in accordance with disposal for routine medical waste.

HOW SUPPLIED

STELFONTA is supplied as a sterile, colorless liquid in a 5 mL clear, single-use glass vial containing 2 mL of STELFONTA at a concentration of 1 mg/mL tigilanol tiglate in sterile water for injection.

REFERENCES

1. Veterinary Cooperative Oncology Group – common terminology criteria for adverse events (VCOG-CTCAE) following chemotherapy or biologic antineoplastic therapy in dogs and cats v1.1. Vet Compar Oncol. 20 Jul 2011.

2. Eisenhauer EA, Therase P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1), Eur J Cancer. 2009; 45(2):228-247.

3. Lynch S, Savary-Bataille K, Leeuw B, Argyle DJ. Development of a questionnaire assessing health-related quality-of-life in dogs and cats with cancer. Vet Compar Oncol. 2011; 9 (3):172-82.

Approved by FDA under NADA # 141-541

STELFONTA® is a registered trademark of QBiotics Group Limited.

Distributed by Virbac AH, Inc.

P.O Box 162059,

Fort Worth, Texas 76161.

Tel. 1-800-338-3659

Version date: August 2020

Client Information Sheet

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STELFONTA 1 MG/ML
tigilanol tiglate injection solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-993
Route of Administration intratumor DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIGILANOL TIGLATE (TIGILANOL TIGLATE) TIGILANOL TIGLATE 1 mg in 1 mg
Product Characteristics
Color white (white to off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-993-02 1 mg in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141541 02/01/2021
Labeler — Virbac AH Inc (131568396)
Registrant — QBiotics Group LTD (744550801)

Revised: 02/2021 Virbac AH Inc

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