Animal NDC 0010-4722-03 Polymast
Hetacillin Potassium
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 0010-4722-03 |
| Proprietary Name | Polymast 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 | Hetacillin Potassium 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 | Boehringer Ingelheim Animal Health Usa Inc. |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| Marketing Category | NADA - NEW ANIMAL DRUG APPLICATION 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. |
| FDA Application Number | NADA055054 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
Polymast 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
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Approved by FDA under NADA # 055-054
Opti-Sert is a registered trademark of Zoetis W LLC - used under license.
POLYMAST is a trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.
© 2020 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.
Made in Italy
472201-01 51744638
Marketed by:
Boehringer Ingelheim Animal Health USA Inc.
Duluth, GA 30096
Caution:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Description:
POLYMAST (hetacillin potassium) is a broad-spectrum agent which provides bactericidal activity against a wide range of common gram-positive and gram-negative bacteria. It is derived from 6-aminopenicillanic acid and is chemically related to ampicillin.
Each 10 mL disposable syringe contains hetacillin potassium equivalent to 62.5 mg ampicillin activity in a stable peanut oil gel. This product was manufactured by a non-sterilizing process.
Action:
Hetacillin provides bactericidal levels of the active antibiotic, ampicillin. In vitro studies have demonstrated susceptibility of the following organisms to ampicillin: Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus and Escherichia coli.
Indications:
For the treatment of acute, chronic or subclinical bovine mastitis. POLYMAST should be used at the first signs of inflammation or at the first indication of any alteration in the milk. Subclinical infections should be treated immediately upon determining, by C.M.T. or other tests, that the leukocyte count is elevated, or that a susceptible pathogen has been cultured from the milk.
POLYMAST has been shown to be efficacious in the treatment of mastitis in lactating cows caused by susceptible strains of Streptococcus agalactiae,Streptococcus dysgalactiae,Staphylococcus aureus and Escherichia coli.
Polycillin® (ampicillin) Susceptibility Test Discs, 10 mcg, should be used to estimate the in vitro susceptibility of bacteria to hetacillin.
Dosage And Administration:
Infuse the entire contents of one syringe (10 mL) into each infected quarter. Repeat at 24-hour intervals until a maximum of three treatments has been given.
If definite improvement is not noted within 48 hours after treatment, the causal organism should be further investigated.
Wash the udder and teats thoroughly with warm water containing a suitable dairy antiseptic and dry, preferably using individual paper towels. Carefully scrub the teat end and orifice with 70% alcohol, using a separate swab for each teat. Allow to dry.
POLYMAST is packaged with the Opti-Sert® Protective Cap.
For partial insertion: Twist off upper portion of the Opti-Sert Protective Cap to expose 3–4 mm of the syringe tip.
For full insertion: Remove protective cap to expose the full length of the syringe tip.
Insert syringe tip into the teat canal and expel the entire contents of one syringe into each infected quarter. Withdraw the syringe and gently massage the quarter to distribute the medication.
Do not infuse contents of the mastitis syringe into the teat canal if the Opti-Sert Protective Cap is broken or damaged.
Residue Warnings:
Milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food. Treated animals must not be slaughtered for food until 10 days after the latest treatment.
Precautions
Because it is a derivative of 6-aminopenicillanic acid, POLYMAST has the potential for producing allergic reactions. Such reactions are rare; however, should they occur, treatment should be discontinued and the subject treated with antihistamines, pressor amines, such as epinephrine or corticosteroids.
The drug does not resist destruction by penicillinase and, hence, is not effective against strains of staphylococcus resistant to penicillin G.
Storage:
Do not store above 25°C (77°F). Do not freeze.
How Supplied:
POLYMAST is supplied as 10 mL syringes containing 62.5 mg ampicillin activity per syringe. One display carton contains 12 syringes. One pail contains 144 syringes.
NDC 0010-4722-01 - 10 mL syringe; NDC 0010-4722-02 -12 syringes; NDC 0010-4722-03 - 144 syringes.
Principal Display Panel – 12 X 10 Ml Syringe Display Carton
NDC 0010-0010-4722-02
PolyMast®
(hetacillin potassium)
Intramammary Infusion
Equivalent to 62.5 mg ampicillin
Caution: Federal law restricts this drug to use by on on the order of a licensed veterinarian.
For lacating cows only
Net Contents: 12 x 10 mL syringes
Approved by FDA under NADA # 055-054
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.