ALBADRY PLUS- novobiocin sodium and penicillin g procaine injection, solution

Albadry Plus by

Drug Labeling and Warnings

Albadry Plus by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

For the Treatment of Subclinical Mastitis in Dry Cows

For Udder Instillation in Dry Cows Only

FOR USE IN ANIMALS ONLY—NOT FOR HUMAN USE

Restricted Drug—Use Only as Directed (California)

DESCRIPTION

Each 10 mL PLASTET® Disposable Syringe contains:
Novobiocin sodium equiv. to novobiocin	400 mg
Penicillin G procaine	200,000 IU
Chlorobutanol anhydrous; (chloral derivative—used as a preservative); in a special bland vehicle	50 mg

Manufactured by a non-sterilizing process.

INDICATIONS FOR USE

ALBADRY PLUS Suspension is indicated for the treatment, in dry cows only, of subclinical mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.

WARNINGS

• Do not use less than 30 days prior to calving.
• Milk from treated cows must not be used for food during the first 72 hours after calving.
• Treated animals must not be slaughtered for food for 30 days following udder infusion.

PRECAUTION

Administration of this product in any manner other than shown under DOSAGE may result in drug residues.

DOSAGE

Infuse one tube per quarter at start of dry period (but not less than 30 days prior to calving).

Shake Well Before Using

DIRECTIONS FOR USING THE FLEXI-TUBE® SYSTEM

The FLEXI-TUBE is designed to provide the choice of either insertion of the full cannula, as has traditionally been practiced, or insertion of no more than ⅛ inch of the cannula, as recommended by the National Mastitis Council.

• Full Insertion: Remove the blue end cap by pulling straight up as shown. Gently insert the full cannula into the teat canal; carefully infuse the product.
  • 
• Partial Insertion: Remove both the blue end cap and the red cannula by pushing sideways as shown. Gently insert the exposed blue tip into the teat canal; carefully infuse the product.
  • 

ADMINISTRATION

At the time of drying off, but not less than 30 days prior to calving, milk the udder dry. Wash the teats and udder thoroughly with warm water containing a suitable dairy antiseptic. Dry the teats and udder thoroughly. Infuse each quarter using the following procedure. Using the alcohol pads provided, scrub each teat end clean using a separate pad for each teat. Warm ALBADRY PLUS Suspension to body temperature and shake thoroughly. Choose the desired insertion length (full or partial) and insert tip into teat canal. Instill entire contents into the quarter. Massage the udder after treatment to distribute the ALBADRY PLUS Suspension throughout the quarters. Using a suitable teat dip, dip all teats following treatment.

SPL UNCLASSIFIED SECTION

 Discard Empty Container; DO NOT REUSE
KEEP OUT OF REACH OF CHILDREN

STORAGE CONDITIONS

Store at controlled room temperature 20° to 25° C (68° to 77° F).

HOW SUPPLIED

ALBADRY PLUS Suspension is available in unbroken packages of 12–10 mL PLASTET Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads and unbroken packages of 144–10 mL PLASTET Disposable Syringes with 144 individually wrapped 70% isopropyl alcohol pads.

SPL UNCLASSIFIED SECTION

NADA #55-098, Approved by FDA

Made in the United Kingdom for
Zoetis Inc.
Kalamazoo, MI 49007 USA
By Norbrook Laboratories Limited
Newry, BT35 6JP, Northern Ireland
Revised: February 2013

002544I08

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label

10 mL (.33 FI Oz) Suspension

ALBADRY PLUS®
Suspension

penicillin G procaine and novobiocin sodium

DRY COW FORMULA

PRINCIPAL DISPLAY PANEL - 12 x 10 mL Syringe Carton

ALBADRY PLUS®
Suspension

PENICILLIN G PROCAINE AND NOVOBIOCIN SODIUM

DRY COW FORMULA

Indicated for intramammary infusion in the treatment of subclinical mastitis caused by
susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.

Contains: 400 mg novobiocin sodium plus 200,000 IU penicillin G procaine
per 10 mL syringe

NADA #55-098, Approved by FDA
12-10 mL (.33 FI Oz) PLASTET® Disposable Syringes / 12 ALCOHOL PADS INCLUDED

zoetis

PRINCIPAL DISPLAY PANEL - 144 x 10 mL Syringe Pail Label

TAKE TIME
OBSERVE LABEL
DIRECTIONS

ALBADRY PLUS®
Suspension

PENICILLIN G PROCAINE AND NOVOBIOCIN SODIUM

DRY COW FORMULA

Indicated for intramammary infusion in the treatment of subclinical mastitis caused by
susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.

Contains: 400 mg novobiocin sodium plus 200,000 IU penicillin G procaine
per 10 mL syringe

1404000
005544L03

NADA #55-098, Approved by FDA
144-10 mL (.33 FI Oz) PLASTET® Disposable Syringes / 144 ALCOHOL PADS INCLUDED

zoetis

INGREDIENTS AND APPEARANCE

ALBADRY PLUS 
novobiocin sodium and penicillin g procaine injection, solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-3139
Route of Administration	INTRAMAMMARY

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NOVOBIOCIN SODIUM (UNII: Q9S9NQ5YIY) (NOVOBIOCIN - UNII:17EC19951N)	NOVOBIOCIN	400 mg  in 10 mL
PENICILLIN G PROCAINE (UNII: 17R794ESYN) (PENICILLIN G - UNII:Q42T66VG0C)	PENICILLIN G	200000 [iU]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
CHLOROBUTANOL (UNII: HM4YQM8WRC)	50 mg  in 10 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-3139-1	12 in 1 CARTON
1	NDC: 54771-3139-9	10 mL in 1 SYRINGE
2	NDC: 54771-3139-2	144 in 1 PAIL
2	NDC: 54771-3139-9	10 mL in 1 SYRINGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA055098	01/07/1983

Labeler - Zoetis Inc. (828851555)