A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Thallium Warnings, Precautions, Pregnancy, Nursing, Abuse - Thallous Chloride
Thallium Warnings, Precautions, Pregnancy, Nursing, Abuse - Thallous Chloride
WARNINGS
: In
studying patients in whom myocardial infarction or ischemia is known or suspected,
care should be taken to assure continuous clinical monitoring and treatment
in accordance with safe, accepted procedure. Exercise stress testing should
be performed only under the supervision of a qualified physician and in a laboratory
equipped with appropriate resuscitation and suppor t apparatus.
PRECAUTIONS
: Data
are not available concerning the effect of marked alterations in blood glucose,
insulin, or pH (such as is found in diabetes mellitus) on the quality of Thallous
Chloride Tl 201 Injection scans. Attention is directed to the fact that thallium
is a potassium analog, and since the transport of potassium is affected by these
factors, the possibility exists that the thallium may likewise be affected.
GENERAL
Do not use after the expiration time and date (5 days maximum
after calibration time) stated on the label.
Do not use if contents are turbid.
The patient dose should be measured by a suitable radioactivity
calibration system immediately prior to administration.
Thallous Chloride Tl 201 Injection, as all radioactive materials, must be handled
with care and used withappropriate safety measures to minimize external radiation
exposure to clinical personnel. Care should also be taken to minimize radiation
exposure to patients in a manner consistent with proper patient management.
Radiopharmaceuticals should be used only by physicians who are qualified by
training and experience in the safe use and handling of radionuclides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to ev aluate
carcinogenic potential, mutagenic potential, or whether Thallous Chloride Tl
201 Injection affects fertility in males or females.
Ideally, examinations using radiopharmaceuticals, especially
those elective in nature, of a woman of childbearing capability should be performed
during the first few (approximately 10) days following the onset of menses.
Pregnancy Category C
Adequate reproductive studies have not been conducted in animals
with Thallous Chloride Tl 201 Injection. It is also not known whether Thallous
Chloride Tl 201 Injection can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. Thallous Chloride Tl 201 Injection
should not be given to a pregnant woman except when benefits clearly outweigh
the potential risks.
Nursing Mothers
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, nursing should not be undertaken
when a patient is administered radioactive material.
Pediatric Use
Safety and effectiveness in the pediatric population has not
been established.
Geriatric Use
Clinical studies of Thallous Chloride TI 201 Injection did
not include sufficient numbers of subjects aged 65 and over to determine whether
they respond differently from yo unger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger
patients. In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.
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