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
Ultrase Warnings, Precautions, Pregnancy, Nursing, Abuse - Pancrelipase
Ultrase Warnings, Precautions, Pregnancy, Nursing, Abuse - Pancrelipase
WARNINGS
Should hypersensitivity occur, discontinue medication and treat symptomatically.
PRECAUTIONS
General
TO PROTECT ENTERIC COATING, MICROSPHERES MUST NOT BE CRUSHED OR CHEWED.
Where swallowing of capsules is difficult, they may be opened and the
microspheres added to a small quantity of a soft food (e.g. applesauce,
gelatin, etc.) that does not require chewing, and swallowed immediately.
Contact of the microsphere with foods having a pH greater than 5.5 can
dissolve the protective enteric shell.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic
potential. Methacrylic acid, a minor component of the methacrylic acid
copolymer enteric-coating contained in ULTRASEŽ (pancrelipase) Capsules,
has been reported to act as a teratogen in rat embryo cultures. However,
the copolymer enteric-coating of ULTRASEŽ (pancrelipase) Capsules was
not mutagenic by the Ames test, and it did not produce chromosome damage
in a test for unscheduled DNA synthesis in rat hepatocytes.
Pregnancy : Category C.
Animal reproduction studies have not been conducted with ULTRASEŽ (pancrelipase)
Capsules. It is not known whether ULTRASEŽ (pancrelipase) Capsules can
cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. ULTRASEŽ (pancrelipase) Capsules should be given to a pregnant
woman only if the potential benefit outweighs the potential risk to the
fetus.
Nursing Mothers
It is not known whether ULTRASEŽ (pancrelipase) is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when ULTRASEŽ (pancrelipase) Capsules are administered to a
nursing mother.
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