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Quartermaster

WG Critical Care, LLC
HQ Specialty Pharma Corporation


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ATTENTION DOCTOR:

It is your responsibility to inform your client of the warnings stated above so as to avoid adulteration of meat or milk and possible prosecution under Federal law.

DESCRIPTION

Each 10 mL disposable syringe contains 1,000,000 units of Procaine Penicillin G, micronized, and 1 gram of Dihydrostreptomycin base, as Dihydrostreptomycin Sulfate, in an extended action base consisting of 1% w/v Hydrogenated Peanut Oil, 3% w/v Aluminum Monostearate, and Peanut Oil, q.s. Manufactured by a non-sterilizing process.

ACTION

Infusion of antibiotics at the start of the drying off period has the following advantages: (1) it is active against existing infections; (2) it is prophylactic against new infections, during the time when cattle are likely to become infected [1]; (3) the antibiotic remains in the udder for a sufficiently long period to accomplish the intended objective and is not diluted with milk, as is the case in lactation therapy; (4) the danger of drug residues in the milk is reduced.

Antibiotic control is to be considered an adjunct to good herd hygiene management and milking management. Detailed field studies in England and the United States have demonstrated that a program consisting of treatment, at the time of drying off, with a highly effective antibiotic preparation in a slow-release base, and routine dipping of teats after each milking with an effective disinfectant, markedly reduces the incidence of all udder infections at calving [2,3,4].

It has recently been recommended that a disinfectant teat dip be used on unmilked cows, or at least be used for 10 days before parturition [5], to reduce the bacterial challenge to the depleted levels of antibiotic in the teat as freshening is approached [6].

When the herd infection level has been reduced, or when herds are not heavily infected initially, it may be desirable to be selective in treating dry quarters [7].

INDICATIONS

For intramammary use to reduce the frequency of existing infection and to prevent new infections with Staphylococcus aureus in dry cows.

DIRECTIONS FOR USE:

At the last milking prior to drying off, completely milk out cow. Warm the syringe containing Quartermaster Suspension to body temperature; choose the desired insertion length (full or partial) and insert tip into teat canal; slowly infuse the entire contents. Instill the contents of one syringe into each quarter. Discard the syringe after use. Treated teats should then be dipped into an effective teat dip. The teat or quarter should not be manipulated again until the cow freshens. To achieve and maintain a lower frequency of infection, proper dipping of teats during lactation is recommended.

Shake vigorously for 10 seconds immediately before using.

DIRECTIONS FOR USING THE FLEXIBLE TIP SYSTEM:

The flexible tip is designed to provide the choice of either insertion of the full cannula, as has traditionally been practiced, or insertion of no more than 1/8 inch of the cannula, as recommended by the National Mastitis Council.

a. Full Insertion: Remove the white end cap by pulling straight up as shown. Gently insert the full cannula into the teat canal; carefully infuse the product.

a.

b. Partial

Insertion: Remove both the white end cap and the red cannula by pushing sideways as shown. Gently insert the exposed white tip into the teat canal; carefully infuse the product.

b.

WARNINGS

For udder instillation upon drying off only. Not to be used within six (6) weeks of freshening. Not for use in lactating cows. Milk taken from animals within 96 hours (8 milkings) after calving must not be used for food. Animals infused with this product must not be slaughtered for food within 60 days from time of infusion nor within 96 hours after calving.

CAUTION:

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

STORAGE CONDITIONS:

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

HOW SUPPLIED

Quartermaster Suspension is supplied as:

Packers of 12–10 mL (.33 Fl Oz) disposable syringes with 12 convenient single-use isopropyl alcohol pads NDC 44567-901-03

Pails of 144–10 mL (.33 Fl Oz) disposable syringes with 144 convenient single-use isopropyl alcohol pads NDC 44567-901-05

REFERENCES:

[1] Smith, A.; Westgarth, D.R.; Jones, M.R.; Neave, F.K.; Dodd, F.H.; & Brander, G.C., Methods of Reducing the Incidence of Udder Infection in Dry Cows, VETERINARY RECORD 81:504-510, 1967.

[2] Dodd, F.H. & Neave, F.K., Mastitis Control, N.I.R.D. BIENNIAL REVIEWS 1970, pp. 21-60.

[3] Roberts, S.J.; Meek, A.M.; Natzke, R.; & Guthrie, R., A Mastitis Control Program Combining Teat Dipping & Dry Cow Therapy, XIX WORLD VETERINARY CONGRESS (Mexico City, 8/15-21/71), PROCEEDINGS 3:935-939, 1971.

[4] Newbould, F.H.S.; Carey, P.G.; & Barnum, D.A., The Numbers of Intramammary Infections & Teat Duct Colonizations in a Herd of Twins During a Hygiene Experiment, CANADIAN JOURNAL OF COMPARATIVE MEDICINE 34:203-208, 1970.

[5] Neave, F.K. & Jackson, E.R., The Prevention of Intramammary Infection, pp. 15-24 in The Control of Bovine Mastitis (Proceedings, Joint Meeting, British Cattle Veterinary Association & The Agricultural Development Association, Reading University. 1/5-6/71), N.I.R.D., 1971.

[6] Feagan, J.T.; Hehir, A.F.; & White, B.R., The Effectiveness in Control of Mastitis of Iodine as a Post Milking Teat Dip, AUSTRALIAN JOURNAL OF DAIRY TECHNOLOGY 25: 87-90, 1970.

[7] Supplement to Current Concepts of Bovine Mastitis. The National Mastitis Council Inc.,Washington, D.C. 22003, 1972, page 7.

WG Critical Care, LLC

Paramus, NJ 07652

Quartermaster is a trademark of West Agro, Inc.

wgCriticalCare

Rev. 11/2013

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 44567-901-03

Quartermaster Suspension

penicillin-dihydrostreptomycin in oil

WG Critical Care

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 44567-901-05

Quartermaster Suspension

penicillin-dihydrostreptomycin in oil

WG Critical Care

Quartermaster

penicillin in dihydrostreptomycin SUSPENSION

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:44567-901
Route of Administration INTRAMAMMARY DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PENICILLIN G PROCAINE Penicillin G 1000000 [iU]
DIHYDROSTREPTOMYCIN SULFATE

Inactive Ingredients

Ingredient Name Strength
PEANUT OIL, HYDROGENATED
ALUMINUM MONOSTEARATE
PEANUT OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 SYRINGE
2 10 in 1 SYRINGE
3 NDC:44567-901-05 144 in 1 PAIL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA055028 2014-06-06


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