PenOne Pro

Manufacturer
MWI Veterinary Supply Co | Norbrook Laboratories Limited
Effective date
2023-06-01
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:42:04

Label at a glance#

ProductPenOne Pro
Active ingredientpenicillin G procaine
Label structure11 sections

Dosage and administration

A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized in boiling water for 15 minutes). Before withdrawing the solution from the bottle, disinfect the rubber cap top with 70% alcohol. The injection site should be similarly disinfected with alcohol. Needles of 16 to 18 gauge and 1 to 1.5 inches long are adequate for intramuscular injections. In li...

Storage and handling

PenOne Pro™ should be stored between 2 to 8°C (36 to 46°F). Restricted Drug - California. Use Only as Directed. Rev Date: Nov 2022 Made in the UK. Norbrook Laboratories Limited Newry, Northern Ireland Distributed by: MWI Boise, ID 83705 www.vetone.net VET one ®

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 065-010

VETone®

PenOne Pro™

PENICILLIN G PROCAINE INJECTABLE SUSPENSION U.S.P.

Injection

For use in Cattle, Sheep, Swine and Horses.

ANTIBIOTIC

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

READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT

Description:

DESCRIPTION SECTION

PenOne Pro™ is a suspension of penicillin G procaine in 100, 250, and 500 mL multiple dose vials. Each mL is designed to provide 300,000 units of penicillin G as procaine in a stable suspension. Penicillin G procaine is an antibacterial agent which has activity against a variety of pathogenic organisms, mainly in the Gram-positive category.

Indications:

INDICATIONS & USAGE SECTION

PenOne Pro™ is indicated for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix rhusiopathiae in swine, and strangles caused by Streptococcus equi in horses.

Directions for Use:

DOSAGE & ADMINISTRATION SECTION

A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized in boiling water for 15 minutes). Before withdrawing the solution from the bottle, disinfect the rubber cap top with 70% alcohol. The injection site should be similarly disinfected with alcohol. Needles of 16 to 18 gauge and 1 to 1.5 inches long are adequate for intramuscular injections.

In livestock intramuscular injections should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle, such as rump, hip, or thigh region; avoid blood vessels and major nerves. Before injecting the solution, pull back gently on the plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw the needle and select a different site.

Dosage:

DOSAGE FORMS & STRENGTHS SECTION

PenOne Pro™ is administered by the intra- muscular route. The product is ready for injection after warming the vial to room temperature and shaking to ensure a uniform suspension. The daily dose of penicillin is 3,000 units per pound of body weight (1 mL per 100 lbs body weight). Continue daily treatment until recovery is apparent and for at least one day after symptoms disappear, usually in two to three days.

Treatment should not exceed four consecutive days.

No more than 10 mL should be injected at any one site. Rotate injection sites for each succeeding treatment.

Care of Sick Animals:

SPL UNCLASSIFIED SECTION

The use of antibiotics in the management of diseases is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by penicillin-susceptible organisms, most animals treated with PenOne Pro™ show a noticeable improvement within 24 to 48 hours. If improvement does not occur within this period of time, the diagnosis and course of treatment should be re-evaluated. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian.

Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, costs and needless losses. Good housing, sanitation and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease.

Residue Warnings:

RESIDUE WARNING SECTION

Exceeding the daily dosage of 3,000 units per pound of body weight, administering for more than four consecutive days, or exceeding the maximum injection site volume per injection site may result in antibiotic residues beyond the withdrawal time. Milk taken from treated dairy animals within 48 hours after the last treatment must not be used for food. Discontinue use of this drug for the following time period before treated animals are slaughtered for food:

Cattle – 14 days, Sheep – 9 days, Swine – 7 days.

A withdrawal period has not been established for this product in pre- ruminating calves. Do not use in calves to be processed for veal.

Warning:

WARNINGS SECTION

Do not use in horses intended for human consumption. Not for use in humans.

Keep out of reach of children.

Precautions:

PRECAUTIONS SECTION

Intramuscular injection in cattle, sheep, and swine may result in a local tissue reaction which persists beyond the withdrawal period of 14 days (cattle), 9 days (sheep), or 7 days (swine). This may result in trim loss of edible tissue at slaughter.

Allergic or anaphylactic reactions, sometimes fatal, have been known to occur in animals hypersensitive to penicillin and procaine. Such reactions can occur unpredictably with varying intensity. Animals administered penicillin G procaine should be kept under close observation for at least one half hour. Should allergic or anaphylactic reactions occur, discontinue use of the product and call a veterinarian. If respiratory distress is severe, immediate injection of epinephrine or antihistamine following manufacturer's recommendations may be necessary.

As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. A lack of response by the treated animal, or the development of new signs or symptoms suggest that an overgrowth of nonsusceptible organisms has occurred. In such instances, consult your veterinarian.

It is advisable to avoid giving penicillin in conjunction with bacteriostatic drugs such as tetracyclines.

To report a suspected adverse reaction call 1-866-591-5777.

Storage Conditions:

STORAGE AND HANDLING SECTION

PenOne Pro™ should be stored between 2 to 8°C (36 to 46°F).

Restricted Drug - California.

Use Only as Directed.

Rev Date: Nov 2022
Made in the UK.
Norbrook Laboratories Limited

Newry, Northern Ireland

Distributed by:
MWI
Boise, ID 83705
www.vetone.net
VETone®

Principal Display Panel - 500 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13985-036-05

500 mL

VETone®

PenOne Pro™

(penicillin G procaine injectable suspension)

Injection

300,000 UNITS PER mL

ANTIBIOTIC

FOR INTRAMUSCULAR INJECTION ONLY

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

Approved by FDA under NADA # 065-010

V1 501178

Net Contents: 500 mL

Principal Display Panel - 500 mL Vial Label
Principal Display Panel - 500 mL Vial Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
745303penicillin G procaine 300000 UNT/ML Injectable SuspensionSCD4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
ea092e41-01a8-4781-b199-b94446808a52Product name120190205
af7816cd-473e-4681-8ef5-5d4b569ced61Product name120151014
b37c02b5-6cf5-47fd-aab5-d510a02bbac0Product name120151014
0f47357f-4a94-e9f0-4fab-2eb6732c6263Product name120140508
11e45d82-8b7a-98b7-67b2-842a15f88536Product name120140508
6ccfe771-a97a-e261-3fb2-bf8e525d1fe0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-036-02PenOne Pro100 mL in 1 VIAL, GLASSINJECTION, SUSPENSION1004
13985-036-04PenOne Pro250 mL in 1 VIAL, GLASSINJECTION, SUSPENSION2504
13985-036-05PenOne Pro500 mL in 1 VIAL, GLASSINJECTION, SUSPENSION5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-036PENONE PRO (PENICILLIN G PROCAINE) INJECTION, SUSPENSION [MWI VETERINARY SUPPLY CO]43 package rows20230609_4049a09f-422f-4220-99ef-8dd6b846945b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
penicillin G procaineACTIVE INGREDIENT17R794ESYN1
penicillin GACTIVE MOIETYQ42T66VG0C1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13985-03613985-036-02, 13985-036-04, 13985-036-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.