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Animal NDC 11695-7046-4 Pancreatic Enzyme Concentrate

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-7046-4
Proprietary Name Pancreatic Enzyme Concentrate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Pancreatic Enzyme Concentrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Covetrus North America
Product Type Otc Animal Drug
Usage Information
    For use as a digestive aid in replacement therapy where digestion of protein, carbohydrate, and fat is inadequate due to exocrine pancreatic insufficiency in dogs and cats.
Active Ingredient(s)
  • Pancrelipase Protease
  • Pancrelipase Lipase
  • Pancrelipase Amylase
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Pancreatic Enzyme Concentrate Images

Pancreatic Enzyme Concentrate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Caution:



Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only

Keep out of reach of children


Description:



This product is a pancreatic enzyme concentrate of porcine origin.


Indications:



For use as a digestive aid in replacement therapy where digestion of protein, carbohydrate, and fat is inadequate due to exocrine pancreatic insufficiency in dogs and cats.


Each Tablet Contains A Minimum Of:



Lipase        9,000 USP units

Protease   57,000 USP units

Amylase   64,000 USP units

Each 2.8g (1 teaspoon) of powder contains a minimum of:

Lipase        71,400 USP units

Protease   388,000 USP units

Amylase   460,000 USP units


Dosage:



Tablets

Pancreatic Enzyme Concentrate is administered before each meal.  Consult with your veterinarian for the appropriate dose based on the severity of the condition and weight of the animal.

Average dose/meal:

Dogs: 2 - 3 tablets

Cats: 1/2 - 1 tablet

Powder

Pancreatic Enzyme Concentrate should be administered with a small amount of food before each meal.  Consult your veterinarian for the appropriate dose based on the severity of the condition and weight of the animal. Add the recommended dose to moistened food (canned or dry) and mix thoroughly to bring the enzymes in contact with the food particles. Let the mixture sit at room temperature for 20 minutes before feeding. Follow with the remainder of the meal.

Average dose/meal:

Dogs: 3/4 - 1 teaspoon (2.8g/teaspoon)

Cats: 1/4 - 3/4 teaspoon


Precautions:



Tablet

Discontinue use in animals with symptoms of sensitivity or allergy. Consult with your veterinarian regarding dosing.

Powder

Discontinue use in animals with symptoms of sensitivity or allergy. May cause temporary oral mucosal irritation that is treatable by reducing dose or diluting dose with a small amount of water. Consult your veterinarian regarding dosing.


Store In Tightly Closed Container In A Dry Place At Temperatures Between 59° And 86°F (15° - 30°C).




* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.