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Tuesday, January 18,1949

FEDERAL REGISTER

the amount of active penicillin absorbed. amounts of the drug into infected quar As a general rule, the amount of penicil ters can be depended upon to overcome lin required for effective therapy when the infection in a majority 75% or given by mouth is five times the amount more of Streptococcus agalactiae mas required by injection. With the possible titis cases:
exception of small-animal practitioners, i Aqueous solutions sodium, calcium, veterinarians will probably find it im or crystalline penicillin dissolved in ster practicable to use penicillin in this form. ile distilled water:
Buffered penicillin tablets may be of a Inject 25,000 to 30,000 units under value in some cases in which it is not pos aseptic conditions through the teat canal sible to administer the drug by injection into each infected quarter. Repeat after at the required intervals and in others each milking or once every 12 hours until after the disease has been brought under five to seven injections have been made.
control by penicillin injections, and it is One repeat injection may be sufficient in desirable to continue the use of the drug. the chronic form without induration.
The tablets may be given alone or as a b In cows producing up to 40 pounds supplement to parenteral therapy. In all of milk per day a total of 100,000 units serious, conditions, however, parenteral per infected quarter administered as five administration is the recommended route. injections of 20,000 units each at inter 3
By topical application. Topical vals of 12 hours or as four injections of application includes direct injection of 25.000 units each at intervals of 24 hours.
penicillin suspended in suitable vehicles In cows producing more than 40 pounds into udders through the teat canal, into of milk per day or in acute cases a total abscesses, joint capsules, body cavities, of 200,000 units per infected quarter ad the spinal canal, and direct application ministered as four injections of 50,000
to the skin and eyes. The underlying units each at intervals of 24 hours. It purpose of this method is to insure ef may be desirable to skip one milking fective therapeutic concentrations of the after the last injection in the series to drug in local areas of infection. In many prolong a therapeutic concentration of instances it may be used as an adjunct penicillin in the treated quarters. Vol to parenteral injections. However, after ume of vehicle should be adequate to parenteral injection penicillin does not favor immediate distribution throughout penetrate readily to the eyes, into spinal the cistern area. Usually 50 cc. is fluid, or, unless in extremely high unitadequate.
age, into the milk. Therefore the topical c Large udders: First day, 200,000
method appears to be the only practica units per infected quarter; second and ble one of treating local infections in third days, 100,000 units per infected volving the eyes, spinal canal, or udder. quarter each day. Small to moderate c Dosage 1 Systemic infections. sized udders: First day, 100,000 units per Por therapy of systemic infections caused infected quarter; second and third days, by most strains of penicillin-sensitive or 50.000 units per infected quarter each ganisms a minimum of 2,000 units per day. All quarters infected with Strepto pound of body weight should be admin coccus agalactiae at the time of drying istered, preferably by intramuscular in off should be infused with 100,000 to jection. Further information concerning 200.000 units sometime during the dry this recommendation may be obtained by period, preferably during the interval request from the Food and Drug Ad between 2 weeks after the last milking ministration. The required dosage of and 3 weeks before parturition.
water-soluble salts of penicillin dissolved ii Emulsified solutions soluble salts in proper aqueous solvents should be re of penicillin dissolved in oil and water peated every 3 to 4 hours to establish and emulsified with lanolin derivatives: In maintain effective therapeutic concen ject 100,000 units under aseptic condi trations of the drug in the body fluids tions through the teat canal into each and tissues. The necessary amount of infected quarter. Repeat treatment if penicillin in oil and wax should be given subsequent bacteriological examination every 12 hours. The indicated quantity shows infection to be still present.
of procaine penicillin in oil or of certain iii Bougies 25,000 or more units of of the newer certifiable repository peni sodium, calcium, potassium, or procaine cillin products may be given as infre penicillin in a milk-soluble base shaped quently as once every 24 hours or longer. in slender, elongated form to permit easy However, severe infections or infections insertion into the milk cistern of the caused by less sensitive organisms may udder through the teat canal. Aseptirequire up to double the minimum dos cally insert one bougie into each infected age or more frequent injections or both. quarter after each milking for as long as Since the objective of penicillin therapy the infection persists.
is to bring the infection under control as iv Oil and wax suspensions cal quickly as possible, the minimum dosage cium or crystalline penicillin in refined or frequency of injection or both should peanut or sesame oil and white wax and be increased materially in all conditions ointments calcium or crystalline peni known to be caused by sensitive organ cillin in an ointment base suitable for isms if no definite indication of clinical udder instillation. In view of the improvement is noticed 12 to 14 hours scarcity of information concerning this after the initial injection. .
use of such products, basic directions for 2 Bovine Streptococcus agalactiae use may be different in individual cases.
mastitis. Effective treatment of udders Adequacy of directions as a whole de infected with penicillin-sensitive organ pends primarily on the penicillin po isms depends on maintaining therapeu tency of each product and the nature of tically effective concentrations of peni supportive data.
cillin in the area of infection. Available 3 General. Whenever practicable, experimental data indicate that the fol accurate diagnosis should be established lowing methods for introducing adequate by identification of the causative organ-

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ism. No case of mastitis should be con sidered cured unless bacteriological ex amination of the milk taken from treated quarters approximately 3 weeks after the last application of penicillin shows the absence of causative organ isms. Augmenting penicillin therapy with proper surgical treatment yields best results when treating abscesses, empyema, suppurative arthritis, and in fections of body cavities and joints caused by penicillin-sensitive organisms.
Collections of pus should be removed prior to each local application of 25,000
to 50,000 units of penicillin in sterile aqueous solution two to three times every 24 hours. Sterile dressings, saturated with an aqueous solution containing at least 1,000 units of penicillin per milli meter, applied one or more times per day as the condition indicates, may be effec tive for treating superficial infections of the skin caused by penicillin-sensitive organisms. If indicated, supplement lo cal therapy with systemic medication.
d Precautions. If reactions occur which cannot be adequately controlled and are more serious than the condition being treated, use of the drug should be discontinued.
Dated: January 12, 1049.
seal

J . D onald K ingsley ,
Acting Administrator.
F. R. Doc. 49-402; Filed, Jan. 17, 1949;
8:48 a. m.

TITLE 38 PENSIONS, BONUSES, AND VETERANS RELIEF
Chapter I Veterans Administration P a r i 3 V eterans C laims PRESUMPTIONS OF SERVICE CONNECTION
FOR CHRONIC AND TROPICAL DISEASE

Section 3.1502 a 1 i and c are amended to read as follows and a new paragraph e is added.
3.1502 Presumptions of service-con nection for chronic and tropical dis eases.
a Provisions of section 1, Public Law 748.

1

i Chronic diseases.
Bronchiectasis.
Calculi of the kidney, bladder, or gall blad der.
Cirrhosis of the liver.
Coccidiomycosis.
Osteomalacia.
Other organic diseases of the nervous sys tem.
Scleroderma.
Raynauds disease.
Tumors of the peripheral nerves.
Ulcer peptic gastric or duodenal.

c Rebuttal of presumption of serv ice-connection. The expression clear and unmistakable evidence appearing in Veterans Regulation 1 a, Part II, paragraph I d 38 U. S. C. ch. 12, shall be construed to be synonymous with the expression affirmative evidence to the contrary contained in Veterans Regulation 1 a, P arti, paragraph I c.
As to tropical diseases incurred in either wartime or peacetime service, the fact