---------- Forwarded message ----------
Date: Sat, 5 Feb 1994 13:59:43 -0500 (EST)
From: Stephen B. Ronan <email@example.com>
Subject: BST WARNING LABEL
Someone from UC Davis recently posted, on an agriculture discussion list,
the text of the warning label that Monsanto is required to include as an
insert with each sale of its version of BST (brand-name: Posilac). The
following is the text of Monsanto's warning label.
(sterile sometribove zinc suspension)
POSILAC (sterile sometribove zinc suspension) is a sterile
prolonged-release injectable formulation of a recombinant DNA-derived
bovine somatotropin analogue in single-dose syringes each containing 500
mg of sometribove zinc.
Indications For Use:
POSILAC is for use in healthy lactating dairy cows to increase production
of marketable milk.
Inject one syringe of POSILAC every 14 days beginning during the 9th week
after calving and continuing until the end of lactation.
Allow syringes to warm to room temperature (15 to 30C; 59 to 86F) before
Inject POSILAC subcutaneously (under the skin) in the postcapular region
(behind the shoulder) or in the depression on either side of the tailhead
(see diagrams below). The injection site should be free of surface
debris. Attach a needle securely to a syringe and inject entire contents
subcutaneously. Do not reuse needles or syringes.
Avoid prolonged or repeated contact of POSILAC with eyes and skin. POSILAC
is a protein. Frequent skin contact with proteins in general may produce
an allergic skin reaction in some people. Alway wash hands and skin
exposed to POSILAC with soap and water after handling.
Clothing soiled with the product should be laundered before reuse.
Not for human use.
Keep out of reach of children.
Precautions and Side Effects:
Use in lactating cattle only.
Safety to replacement bulls from dairy cows injected with POSILAC has not
To minimize injection site blemishes on the carcass at time of slaughter,
avoid injections of POSILAC within 2 weeks of expected slaughter.
Feed intake increases over several weeks after initiating the use of
POSILAC. This increase occurs earlier for first calf heifers than for
second lactation or older cows. Use of POSILAC may reduce the amount of
body condition that is normally regained during lactation. This effect is
more pronounced for second lactation or older cows. Voluntary feed
intake may be increased and body condition decreased during both the dry
period and subsequent early lactation.
Cows should be fed diets formulated to meet or exceed the nutritional
requirements recommended by the National Research Council. Milk yield,
stage of lactation, and body condition should be considered when making
dietary changes. The feeding program should be managed to optimize energy
intake and to have cows in appropriate body condition particularly during
late lactation and the dry period.
Use of POSILAC (sterile sometribove zinc suspension) may result in reduced
pregnancy rates in injected cows and an increase in days open for first
calf heifers. Use of POSILAC has also been associated with increases in
cystic ovaries and disorders of the uterus during the treatment period.
Cows injected with POSILAC may have increased twinning rates. Also, the
incidence of retained placenta may be higher following subsequent calving.
Use of POSILAC should be preceded by implementation of a comprehensive and
ongoing herd reproductive health program.
Cows injected with POSILAC are at an increased risk for clinical mastitis
(visibly abnormal milk). The number of cows affected with clinical
mastitis and the number of cases per cow may increase.
In addition, the risk of subclinical mastitis (milk not visibly abnormal)
is increased. In some herds, use of POSILAC has been associated with
increases in somatic cell counts. Mastitis management practices should be
thoroughly evaluated prior to initiating use of POSILAC.
Use of POSILAC is associated with increased frequency of use of medication
in cows for mastitis and other health problems.
Cows injected with POSILAC may experience periods of increased body
temperature unrelated to illness. To minimize this effect, take
appropriate measures during periods of high environmental temperature to
reduce heat stress. Care should be taken to differentiate increased body
temperature due to use of POSILAC from an increased body temperature that
may occur due to illness.
Use of POSILAC may result in an increase in digestive disorders such as
indigestion, bloat, and diarrhea.
There may be an increase in the number of cows experiencing periods of
"off-feed" (reduced feed intake) during use of POSILAC.
Studies indicated that cows injected with POSILAC had increased numbers of
enlarged hocks and lesions (e.g. lacerations, enlargements, calluses) of
the knee (carpal region), and second lactation or older cows had more
disorders of the foot region. However, results of these studies did not
indicate that use of POSILAC increased lameness.
Injection Site Reactions.
A mild transient swelling of 3-5 cm (1-2 inches) in diameter may occur at
the injection site beginning about 3 days after injection and may persist
up to 6 weeks following injection.
Some cows may experience swellings up to 10 cm (4 inches) in diameter that
remain permanent but are not associated with animal health problems.
However, if permanent blemishes are objectionlble to the user,
administration of the product to the particular animal should be
discontinued. Use of POSILAC in cows in which injection site swellings
repeatedly open and drain should be discontinued.
Additional Veterinary Information:
Care should be taken to differentiate increased body temperature due to
use of POSILAC from an increased body temperature that may occur due to
Use of POSILAC has been associated with reductions in hemoglobin and
hematocrit values during treatment.
Milk production response during each 14-day injection period is cyclic and
will be greatest during the middle of each period.
No milk discard or preslaughter withdrawal period is required.
Store under refrigeration (2 to 8C; 36 to 46F.) DO NOT FREEZE. Avoid
prolonged exposure to excessively high temperature and sunlight to prevent
a decrease in product activity. Expiration dates are stated on syringe
and carton labeling.
Used syringes and needles should be placed in a leak-resistant,
puncture-resistant container for disposal in accordance with applicable
Federal, state, and local regulations.
How Supplied: Single-dose syringes in 25-pack cartons.
NADA # 140-872, Approved by FDA
Manufactured and packaged for
ANIMAL SCIENCES DIVISION
OF MONSANTO COMPANY
ST. LOUIS, MISSOURI 63167, U.S.A.
Made in Austria
Filled and packeaged in The Netherlands